national guidelines and training module for kala-azar...
TRANSCRIPT
National Guidelines and Training
Module for Kala-azar Elimination
in Bangladesh
Kala-azar Elimination Program, Disease Control Unit
Directorate General of Health Services
Supported by: World Health Organization
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First Edition, January-2008 Government of Bangladesh
Printed in Dhaka
Acknowledgement
We are grateful to WHO Bangladesh for technical support in
development of this module.
Copyright
The copyright of this module for doctors on Kala-azar Elimination
Program is of Communicable Diseases Control Division of Directorate
General of Health Services, Ministry of Health and Family Welfare,
Government of the Peoples Republic of Bangladesh.
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Patron : Professor M. A. Faiz,
Director General of Health Services
Chief Editor : Prof.Dr.Moazzem Hossain,
Director, Disease Control &
Line Director, CDC, DGHS.
Board of Editors:
1 Introduction & Kala-azar Elimination programme
a) Prof. Ridwanur Rahman Professor of Medicine, Khaleda Zia Medical College
b) Dr.A.M.Bangali N P O (VBD) WHO
c) Dr.Humayun Kabir Associate Prof. CME
d) Dr.Farida BegumNaher DPM Kala-azar,CDC, DGHS
e) Dr.Sarwar Mahboob Medical Officer (Epidemiology) IEDCR
2 Diagnosis & Treatment
a) Prof.Md.Zaforullah Chowdhury Director,NIPSOM
b) Prof.Saiyeedur Rahman Professor Of Medicine Mymensingh Medical College
c) Prof.Akhtarun Naher Professor Of Microbiology, NIPSOM
d) Prof.AKM.Shariful Islam Professor Of Skin & VD, Faridpur Medical College
e) Dr.Quazi Tarikul Islam Associate Prof, Medicine, Rajshahi Medical College
f) Dr.Aliya Rashid Lecturer Microbiology, Dhaka Medical College
g) Dr.Syed Md.Arif Associate Prof. Dhaka Medical College
h) Dr.Robed Amin Junior Consultant, UHC, Hathazari, Chittagong
i) Dr.Aniruddha Ghose RMO, Chittagong General Hospital
j) Dr. Nilufar Begum Associate Prof. Microbiology, NIPSOM
k) Dr.A.B.Al Mamun Medical Officer, Fialria project
3 Serveillance & Reporting
a) Prof.Mahmudur Rahman Director, IEDCR
b) Dr. Be-Nazir Ahmed Senior Scientific Officer, IEDCR
c) Dr.Kazi M.Jamil ICDDRB
d) Dr.Ziauddin Ahmed Consultant Kala azar, WHO
e) Dr.Modon Gopal Dutta Assistant Director,CDC, DGHS
f) Dr.AKM.Muazzem Hossein Deputy Director & PM M&PDC,DGHS
g) Dr.Mirza Al Mamun Epidemiologist, DGHS
4 Integrated Vector Management
a) Prof.Shireen Akhter Professor Of Microbiology, NIPSOM
b) Prof.Shamsun Nahar Begum Professor, CME
c) Dr.Sarah Banu Scientific Officer, IEDCR
d) Mr.A.R.Chowdhury WHO
e) Dr.Harun ar Rashid Assistant Director CDC, DGHS
f) MrsNuzhatNasreenBanu IEDCR (Entomologist)
g) Mr.Touhiduddin Ahmed Ex-Principal Scientific Officer
h) Mr.NP Maheswary Ex-Entomologist
5 Behavior Change Communication
a) Dr.AMN.Zaman Assistant Director, PHC,DGHS
b) Mr.Nur Mohammad BHE, DGHS
c) Dr.Jahanara Begum Associate Prof. NIPSOM
d) Dr.Md.Abdur Raquib DPM, Filaria Project
e) Dr.M.Mushtuq Hossein IEDCR
f) Dr.Ahmad Raihan Sharif Medical Officer, Control room, DGHS
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CONTENTS
Page no
Abbreviations …………………………………………………………………...7
1. Introduction ………………………………………………………….……….....9
1.1 Background ……………………………………………………………....…10
1.2 Kala-azar situation in Bangladesh …………………………………………11
1.3 Target audience for the guidelines..........................................................…...13
1.4 Selection of the levels of Health facilities for elimination programme........13
1.5 Kala-azar elimination programme……………………………………….....14
1.5.1 Target ………………………………………………………………..……15
1.5.2 Objectives ………………………………………………………………...15
1.5.3 Regional strategy…………………………………………….…………....15
2. Diagnosis of Kala-azar & PKDL..........................................................................17
2.1 Life cycle, pathogenesis, pathophysiology ………………………………....18
2.2 Pathogenesis of Kala-azar ………………………………………………......20
2.3 Pathophysiology of Kala-azar ………………………………………............20
2.4 Pathophysiology of Post Kala-Azar Dermal Leishmaniasis (PKDL)…….....20
2.5 Clinical presentation of Kala-azar ............. ………………………………....21
2.6 Complication of Kala-azar..................... ………………………………….....23
2.7 Complication of (PKDL)...................................................……………..........24
2.8 Laboratory diagnosis of Kala-azar...................................................................24
2.9 Supportive supervision....................................................................................28
2.10 Quality Assurance ..........................................................................................28
2.11 Rapid diagnosis of Kala-azar..........................................................................29
2.12 Diagnosis of PKDL by ‘rK-39’ test...............................................................29
2.13 Bone marrow investigation ............................................................................32
2.14 Splenic aspiration ...........................................................................................32
2.15 Diagnosis of Kala-azar in special situation ....................................................32
2.16 Clinical case definition of Kala-azar & PKDL ..............................................32
2.17 Case definition for reporting ..........................................................................35
2.18 Differential Diagnosis ....................................................................................35
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3. Treatment of Kala-azar & PKDL……………………………………………....38
3.1 Drug treatment of Kala-azar ………………………………….....................39
3.2 Complete treatment of Kala-azar…………………………………………...44
3.3 Pharmaco-vigilance ………………………………………………………...45
3.4 Treatment of Kala-azar in special situations ..................................………...46
3.5 Treatment of Kala-azar at different levels of health facilities ………..……49
4. Kala-azar surveillance and Reporting System …………………………………51
4.1 Background & introduction....……………………………………………...52
4.2 Reporting system …………………………………………………………..52
4.3 Surveillance of Kala-azar and PKDL ……………………………………....62
5. Integrated Vector Management ………………………………………………...66
5.1 Vector behaviour and bionomics …………………………………………...67
5.2 Integrated vector management ……………………………………………..68
5.3 Key steps to be undertaken in planning ………………………………........69
5.4 Vector control options………………………………………………….......70
5.5 Indoor residual spray (IRS)…………………………………………….......70
5.6 Vector surveillance …………………………………………………….......81
5.7 Monitoring of insecticide resistance …………………………….…….........82
5.8 Personal protection.........................................................................................82
5.9 Microenvironmental management.................................................................84
5.10 Research.......................................................................................................84
6. Behavior change communication …………………………………….…….......86
6.1 Background …………………………………………………..…………......87
6.2 The need for behaviour change ………………………………..…………....87
6.3 Behaviour change for impact …………………………………..…………...87
6.4 Advocacy for behaviour change ………………………………..…………..88
6.5 Key steps for planning for behaviour change ………………………..……..89
6.6 Key messages to achieve the behaviour change objectives…………..….….93
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7. Case Summery
Case Summery 1 ................................................................................................95
Case Summery 2 ................................................................................................96
Case Summery 3 ................................................................................................97
Key References ..................................................................................................98
Annexes
1. Life cycle of leishmania donovani.....……………………………………………99
2. Method of diagnosis of Kala-azar………………………………………………...100
3. Collection of blood sample....……………………………………………………101
4. Serological test.......................................................................... ………………....102
5. Bone marrow aspiration..........................................................…………………..103
6. Splenic aspiration .......................………………………………………………..105
7. Staining & microscopy of SA/BM.........................................…………………...108
8. Promastigote forms for culture...................................................…………...........109
9. PCR ......................................................................................................................110
10. Pharmacological properties of Miltefosine...........................................................111
11. Other drug treatment of Kala-azar ........................................................................112
12. Instruction for spray squad members (Do’s & Don’ts) ………………………….113
13. Spraying Technique ...............................................................................................114
14. Treatment Chart Kala-azar & PKDL .....................................................................116
15. Kala-azar diagnosis & management chart ..............................................................117
16. Pictures of PKDL patients.......................................................................................118
17. Patient refer Form (Upazila) ...................................................................................119
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ABBREVIATIONS
AHI : Assistant Health Inspector
AIDS : Acquired Immuno Deficiency Syndrome
ART : Anti Retroviral Therapy
BCC : Behaviour Change Communication
BM : Bone Marrow
CCF : Congestive Cardiac Failure
CDC : Communicable Disease Control
CLD : Chronic Liver Disease
CME : Centre for Medical Education
CS : Civil Surgeon
DC : Disease Control
DDT : Diethyl-Dichloro-Tri-chloro-ethane
DGHS : Directorate General of Health Services
DNA : Deoxy Ribonucleic Acid
DOTS : Directly Observed Treatment in Short
ECG : Electrocardiogram
ESR : Erythrocyte Sedimentation Rate
FSW : Female Sex Worker
GIS : Geographical Information System
GIT : Gastro Intestinal Tract
GR : Geographical reconnaissance
HA : Health Assistant
HH : House Hold
HIV : Human Immuno-deficiency Virus
HV : Health Volunteers
H&FWC : Health & Family Welfare Centre
ICDDR, B : International Centre of Diarrhoeal Disease & Research, Bangladesh
ICT : Immuno Chromatographic Test
IDU : Intravenous Drug User
IEC : Information, Education & Communication
IEDCR : Institute of Epidemiology, Disease Control & Research
IM : Intramuscular
IPD : In Patient Door
IRS : Indoor Residual Spray
ITN : Insecticide Treated Net
IV : Intravenous
KA : Kala-azar
KATF : Kala-azar Treatment Failure
LLITN : Long Lasting Insecticide Treated Net
M & PDC : Malaria & Parasitic Disease Control
MEP : Malaria Eradication Programme
MIS : Medical Information System
MO : Medical Officer
MOU : Memorandum of Understanding
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MPS : Mononuclear Phagocytic System
MSM : Male Sex with Male
NGO : Non Government Organization
NIPSOM : National Institute & Social Medicine
NNN : Novy-MacNeal-Nicolle
NPO : National Professional Officer
OHP : Over Head Projector
OPD : Out Patient Door
ORS : Oral Rehydration Salt
PCR : Polymerase Chain Reaction
PKDL : Post Kala-azar Dermal Leishmaniasis
RD : Rural Dispensary
RDT : Rapid Dipstick Test
RE cells : Reticulo-Endothelial cells
RMO : Residential Medical Officer
RTAG : Regional Technical Advisory Group
SA : Splenic Aspiration
SAG : Sodium Antimony Gluconate
SC : Sub Centre
SEARO : South East Asian Regional Office
SGOT/AST : Aspartate Aminotranferase
SGPT/ALT : Alanine Aminotransferase
SI : Sanitary Inspector
SOP : Standard Operating Procedures
TDR : Tropical Disease Research
UHC : Upazila Health Complex
UHFPO : Upazila Health & Family Planning Officer
WHO : World Health Organization
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Learning Unit-1
INTRODUCTION
Contents:
❖ Background
❖ Bangladesh situation
❖ Target audience
❖ Selection of different level of health facilities
❖ Kala-azar elimination program-
1)-Target-2) Objective-3) Regional strategies
Methods:
❖ Self directed learning/individual reading
❖ Drill
❖ Discussion
❖ Summary by facilitator
Media:
❖ Manual and Guideline
❖ OHP
❖ Multimedia and laptop
Time: 60 minutes
Assessment: question-answer session
Objective of the session:
At the end of the session trainees will be able to-
❖ Describe global, regional and country situation of Kala-azar.
❖ Mention the target audience of their guideline
❖ Identify different level of health facilities in public and private
sector for elimination of Kala-azar.
❖ Define target, objectives and regional strategy of Kala-azar
elimination program.
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1.1 Background
Kala-azar or Visceral Leishmaniasis is one of the complex of diseases, called leishmaniasis and is
caused by the trypanosomatid parasite Leishmania donovani. In the Indian sub-continent it is
transmitted by the sand fly, Phlebotomus argentipes. The disease presents with fever of long
duration (more than two weeks) with splenomegaly, anaemia, progressive weight loss. In endemic
areas, children and young adults are its principal victims. Without timely treatment the disease is
fatal. Kala-azar HIV co-infection has emerged as a health problem in recent years.
Kala-azar is seen in several countries of the world. About 500,000 cases occur annually. Five
countries, namely India, Sudan, Nepal, Bangladesh and Brazil account for 90% of the global
cases. Kala-azar affects largely the socially marginalized and the poorest communities.
In the South East Asian Region, Kala-azar occurs in India, Bangladesh, and Nepal. A small focus
has also been reported from Bhutan. In the three countries of the region about 200 million people
in 109 districts are “at risk”. In India 52 districts in the four States, e.g. Bihar, Jharkhand, West.
Bengal and parts of Eastern Uttar Pradesh are at present endemic for the disease. In Nepal 12
districts, contiguous to the states of Bihar and Uttar Pradesh are endemic whereas in Bangladesh
Kala-azar has been reported in 45 districts. India launched the Kala-azar elimination programme
with effect from December 2003 with the objective of eliminating the disease by 2010.
Bangladesh and Nepal are committed to Kala-azar elimination programme with the target of
achieving disease elimination by 2015. The political commitment for elimination of Kala-azar is
high. In May 2005, the three countries signed a Memorandum of Understanding (MOU), in
Geneva during the World Health Assembly, committing themselves to mutual cooperation
towards elimination of kala-azar from their respective countries. A Regional Strategic Plan has
been prepared and endorsed by the WHO SEARO Regional Technical Advisory Group (RTAG)
and partners supporting elimination. The second meeting of RTAG held in Kathmandu in October
2006 recommended that WHO should prepare guidelines and standard operating procedures to
ensure the application of interventions in the endemic countries uniformly.
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1.2 Kala-azar situation in Bangladesh
Kala-azar is one of the major public health problems in Bangladesh and the disease is endemic
for many decades. During the ‘Malaria Eradication Programme’ blanket DDT spraying
controlled kala-azar transmission. In the late 1970s Kala-azar re-emerged sporadically. During
1981-85 only 8 upazilas (Sub-district) reported Kala-azar, which increased to 105 upazilas in
2004. During the last few years the Kala-azar situation has assumed epidemic proportion with
the number of reported cases increasing from 3978 in 1993 to 8505 in 2005. Present surveillance
is weak and the current estimated total cases are about 45,000. Annually @ 10,000 cases are
treated by the control programme but the cases treated by the private clinics and practitioners are
not reported.
Figure: 1 Kala-azar cases and their distribution in the map
of Bangladesh are shown as indicated by districts:
low endemic-(Blue), moderate endemic-(Grey);
and high endemic-(Red) colour.
The disease is focal with most cases reported
from Rural areas, exhibiting a familial and
contiguous clustering pattern among the lowest
socio-economic groups. The new areas are being
invaded every year posing a challenge
for the control programme.
The only known vector is Phlebotomus
argentipes, which is still amenable to DDT and
pyrethroids.
Under the current surveillance system the Upazila Health Complexes (UHCs), District Hospitals
and other specialized hospitals report cases to the Malaria & Parasitic Disease Control Unit in
DGHS. This is however is a gross under reporting because the private sector clinics and
hospitals, and the cases treated by private practitioners are not included. At present only Inj.
SAG is used for treatment, which is supplied, free of charges and passive surveillance only
works when drugs are available in the hospitals.
Kala-azar Endemic
Districts in Bangladesh
O- High O- Moderate
O- Low
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The bar chart below shows the number of Kala-azar cases reported during 1994-2005. It signifies
the trend of the disease @ of 8,000-10,000 cases annually. The highest case fatality rate recorded
from research on known Kala-azar patients in Mymensingh district has been 6.4% (Desjeux P.
1991). The prevalence rate in some selected villages in the same district has been found be as
high as 6% of the total population (unpublished report, 1993). However, definite data on
morbidity and deaths due to Kala-azar are not available from the current reporting system. Age
and sex segregated data is not available with the control programme at present.
Cases are usually clustered in the villages having environmental and related factors for the
vectors to grow and proliferate. There is no marked seasonal variation but the pre and post-
monsoon rise in number of cases indicates two picks of transmission. Areas in the old
Brahmaputra and the Ganges basin show the highest prevalence of the disease.
Phlebotomus argentipes is the vector of Kala-azar in Bangladesh. The vector habitat is restricted
to the domiciliary and peri-domicillary areas. Favourable conditions for sandfly multiplication as
described by Napier (1926) are: a) a monthly mean temperature between 7.20C- 370C; b) mean
annual relative humidity (RH) of 70% with 80% RH at least for 3 months; c) annual rainfall of
1250 mm or more; d) altitude < 600 m; e) alluvial soil; f) high sub-soil water; and g) abundant
vegetation. These conditions are encountered in most parts of Bangladesh thus the country is
highly receptive. P. argentipes is an indiscriminate feeder and feeds on whatever is in the
vicinity, but if given the choice however it privileges cow and human blood meals. Females may
have up to 4 gonotrophic cycles. The sandflies are endophilic and endophagic. They take short
erratic hops and seldom rise above 2 meter (6 feet) from the ground surface. Dispersal is
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generally less than 300 meter. P. argentipes has been found to be susceptible to DDT, malathion
and synthetic pyrethroids.
1.3Target audience for the guidelines
These guidelines will be useful to the- .
• Programme managers- national/divisional/district/upazilla level.
• Doctors and health care providers
• Supervisors at all levels
• Supervisors and health workers engaged in supervising the spraying squads
• The health care providers and volunteers responsible for behaviour change
communication (BCC) can use the guidelines to (a) promote early care seeking if
Kala-azar is suspected, (b) convince the patients suffering from Kala-azar to
complete the treatment and (c) undertake advocacy with the community for
participation in ensuring complete and uniform coverage of their households with
insecticides.
This guidelines and SOP’s are adopted according to the SEARO, WHO guidelines. Whenever
translation is needed for training of grass root level workers, volunteers, NGO workers for
providing training on particular areas of their involvement in Kala-azar elimination programme,
local managers are encouraged to translate it in ‘Bangla’.
1.4 Selection of the levels of Health Facilities for elimination programme
The classification into levels is based on the needs, severity and range of health problems,
staffing, expected role of the different staff members, and the diagnostic and treatment facilities
provided. This is true for the government and the private sector. It should be guided by the
national policy and norms. Mapping of the district is recommended to choose the different level
facilities to be included for diagnosis and treatment, surveillance, prevention and BCC activities.
Different levels of health services in Bangladesh are summarized in the table below. Adjustments
may be made according to the local circumstances.
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Table 1 Level of health facilities in Bangladesh
Level 1 Level 2 Level 3
Public sector
-Upazila Health Complex
(UHC)
-Community clinic
- Union Health Facilities
(Health & Family Welfare
Centre-H&FWC; Rural
Dispensary-RD; Sub-centre-SC)
Private sector
-Qualified private practitioners
-Non qualified health care
providers including health
volunteers
-NGOs; private hospitals;
private clinics; and private
laboratories.
Public sector
-District Hospitals
Private sector
-Qualified private
practitioners;
NGOs; private hospitals;
private clinics; and
private laboratories.
Public sector
-Medical college Hospitals.
-Specialized hospitals
Private sector
-Medical College Hospitals
-Qualified private
practitioners;
-
NGOs; private hospitals;
private clinics; and private
laboratories
N.B-Treatment will be given in upazilla health complex in case of level I and other private
and public sector of Level I will refer the patient to upazilla health complex.
For the success of the programme it is important to develop linkages between the three levels and
establish ongoing communication with the private sector. The district focal point should be
responsible for sustaining the linkages. The details of collaboration between the public and
private sector need to be worked out with the objective of obtaining uniform standards of
practices.
1.5 Kala-azar elimination programme
Kala-azar can be eliminated from the Indian Subcontinent because there is no intermediate host for
transmission of the disease. The Indoor residual spray has been very effective. As a collateral
benefit of malaria Kala-azar was almost eliminated. The disease can be easily recognized and
effective treatment for Kala-azar is available.
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1.5.1 Target
The target of Kala-azar elimination is to reduce the incidence of the disease to less than 1 case per
10,000 populations at the sub-district (Upazila) level in Bangladesh and India and at the district
level in Nepal which implies a reduction of about 20 times the current incidence.
[NB: A precise area delineation should be done to calculate accurately the current case rate per 10,000
population based on at least 3 years’ data on case reporting for the endemic areas.]
1.5.2 Objectives
The impact objective is to reduce the incidence of Kala-azar to less than 1 case of Kala-azar and
Post Kala-azar Dermal Leishmaniasis per 10,000 population at district (in Nepal) or sub
district/upazila level (in Bangladesh and India) by:
➢ Reducing the incidence Kala-azar in the endemic communities including the poor,
vulnerable and un-reached populations.
➢ Reducing case fatality rates from Kala-azar.
➢ Treatment of Post Kala Azar Dermal Leishmaniasis (PKDL) to reduce the parasite
reservoir.
➢ Prevention and treatment of Kala-azar-HIV-TB co-infections.
1.5.3 Regional strategy
A regional strategy for elimination of Kala-azar has been endorsed by the Regional Technical
Advisory Group (RTAG). It comprises of the following components:
(a) Early diagnosis and complete treatment: All suspected cases of Kala-azar and
PKDL would have access to recommended diagnosis and treatment.
(b) Integrated vector management: The mainstay of vector control is indoor residual spray
(IRS) with suitable insecticides. Improvements in housing and personal preventive
methods would be promoted through community involvement.
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(c) Effective disease surveillance: A revamped surveillance system should strengthen
diagnosis treatment and reporting both in the public and the private sector.
(d) Social mobilization and partnerships: Behavioral Change Communication (BCC) would
aim at achieving early diagnosis and complete treatment, participation of the community in
IRS, and adoption of personal preventive methods and micro-environmental management.
Partnerships within and outside the health sector are to be forged to promote the goals of
Kala-azar elimination.
(e) Operational research: Operational research to monitor the drug and insecticide resistance,
quality of drugs, treatment compliance, pharmaco-vigilance, ITNs use etc. would be
undertaken.
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Learning Unit-2:
DIAGNOSIS OF KALA-AZAR and PKDL
Contents:
Lifecycle, Pathogenesis and Patho-physiology
Clinical Diagnosis of KA and PKDL:
Clinical features of KA and PKDL
Complications of KA and PKDL
Laboratory diagnosis of KA
Direct evidence: Microscopy, PCR, Culture
Indirect evidence: Immunological
Others: Haematological, Biochemical
Laboratory diagnosis of PKDL:
Objectives: at the end of the session the participant will be
able to
• describe lifecycle of L donovani, pathogenesis
and patho-physiology of KA and PKDL
• mention the clinical feature of KA and PKDL
• list the complications of KA
• define a case of KA and PKDL
• measure the spleen
• perform skin sensation test (PKDL)
• perform the rK-39 test
• aspirate bone marrow/ spleen (Optional)
• prepare slides for microscopy (Optional)
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Differential diagnosis
Case definition: KA, PKDL, KATF
2.1 Lifecycle, Pathogenesis and Patho-physiology
Life cycle of Leishmania donovani
Mode of transmission – The natural transmission of Leishmania donovani from man to man is
carried out by a certain species of sand fly of the genera Phlebotomus. The infected female sand fly
transmits LD bodies to the susceptible human through their bite.
CYCLE IN MAN: Flagellated Promastigotes enter the body through infected sandfly bite and
subsequent events are as follows:
Parasites enter the skin
Engulfed by resident macrophages
Promastigotes develop into Amastigotes (L-D bodies) in cells of M.P.S
Amastigotes multiply and R.E. cells are packed with parasites, enlarged, distended &eventually burst
(50 to 200 parasites present in single cell) to release the parasites.
Free parasites pass to different organs of the body and are engulfed by new R.E. cells where they
multiply & the cycle is repeated.
In this way the entire Reticulo-Endothelial system becomes progressively infected.
A blood-sucking sandfly draws Amastigotes (L-D bodies) during its blood-meal
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CYCLE IN SANDFLY: Amastigotes (L-D bodies) are taken with blood meal and develop into
promastigote forms in the midgut of sandfly on the third day after blood meal.
Promastigotes multiply by binary fission into enormous number
Multiplication takes place and on the 5th day the promastigotes gather around the proventricular end
of the gut
Multiplication and forward progression continues till 7th day
Solid mass of flagellates fill up extending up to the pharynx
A heavy pharyngeal infection of the sandfly is usually observed between 6th and 9th day of its infected
blood meal
In certain sandflies heavy infection blocks the oesophagus. Such sandflies, at the time of their next
sucking blood cause regurgitation of promastigotes from their buccal cavity in the puncture wound
through proboscis (biting organ) and infection results
Annex1: Life cycle of Leishmania donovani
.
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2.2 Pathogenesis of Kala-azar
▪ Promastigotes are inoculated on the punctured site by the feeding sandfly. The entry of
organism attracts mononuclear phagocytes (macrophages) and other white cells to the area.
Certain macrophages can directly kill the parasite whereas others require prior stimulation
before attaining the capability to destroy these parasites. Only resident (local) unstimulated
macrophages are suitable for the establishment of the infection. To avoid being killed within
the macrophages, the promastigotes transform themselves to amastigotes.
▪ Leishmania donovani is a species, which tends to visceralize in vertebrate hosts. The
infection is carried to the viscera through infected macrophages circulating in the blood or
lymph. The spleen, liver and bone marrow become heavily infected. The skin may also get
infected as a sequel of Kala-azar.
2.3 Pathophysiology of Kala-azar
▪ The pathology of visceral leishmaniasis is due to blockage and destruction of the
reticuloendothelial system with the most marked effects being seen in the spleen, liver,
lymph glands, bone marrow, and intestines.
▪ In active visceral leishmaniasis there is lack of a cell-mediated immune response to
leishmanial antigens and therefore the parasites multiply rapidly. Humoral response with
production of large amounts of polyclonal non-specific immunoglobulin especially IgG are
found and also specific anti-leishmanial antibody are produced. Patients who have recovered
from visceral leishmaniasis are immune from re-infection but relapses can occur.
2.4 Pathophysiology of Post Kala-azar Dermal Leishmaniasis (PKDL)
➢ In PKDL the epidermis shows several pathological changes in different combinations. These
include hyperkeratosis, parakeratosis, acanthosis, follicular plugging and liquefaction
degeneration of the basal layer. The latter is associated with incontinence of pigment and the
presence of many melanin- containing macrophages in the upper dermis. Damage to the
melanocytes is the cause of hypopigmentation.
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➢ The dermis shows varying intensities of inflammation with scanty parasite, which are best
seen in slit smears of lesions. The infiltrate may be perivascular and band-like in the upper
dermis.
➢ Electron microscopy reveals ineffective stimulation of the macrophage to eliminate
completely all the parasites. Neuritis involving the small cutaneous nerves in the dermis has
been described in PKDL. This may suggest leprosy but lack of involvement of the
superficial nerves and other cardinal signs of leprosy help to distinguish the two conditions
from one another. Parasites can be demonstrated in only 20% of cases.
Epidemiology
Incubation period: Usually 3-6 months, which may range from 10 days to 2 years.
2.5 Clinical Presentation of Kala-azar
A. Classical Presentation
o Fever-usually insidious & may be associated with chills & rigor. Fever intensity
decreases over time and patient may become afebrile for weeks to months followed by
relapse of fever.
o Weight loss
o Swelling of upper abdomen, specially left side.
o Increased pigmentation- a feature of advanced disease.
B. Features of complication
o Bleeding manifestation e.g. Epistaxis, GIT bleeding. This occurs as a result of
thrombocytopenia & hepatic dysfunction.
o Features of secondary infection.
C. Atypical presentation
o Sub clinical-No fever
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Signs
A. General Examination
o Raised temperature.
o Anaemia- moderate to severe; may result from bone marrow infiltration,
hypersplenism, autoimmune haemolysis & bleeding.
o Gum bleeding & epistaxis
o Lymphadenopathy- more common in Africa, less in India.
B. Abdominal Examination
o Splenomegaly – in 100% cases. Develops quickly in the first few weeks and become
massive as the disease progress.
o Hepatomegaly
o Ascites, oedema, asnasarca- in progressive disease, cause by hypoalbuminaemia
Cardinal Clinical feature
o H/O fever more than 2 weeks
o Residing/Traveling in endemic area
o Splenomegaly
o Weight loss
o Anaemia
Clinical Presentation of PKDL
PKDL usually develops 6 months -5 years following an attack of untreated or incompletely
treated visceral leishmaniasis. However, 15% of PKDL cases occur without the preceding
history of Kala-azar. They have only skin lesions that are varied. The lesions may be macular,
papular, nodular or mixed. Sometimes the lesions of PKDL are extensive. Overlapping of 3
stages (Macular, papular and nodular) can occur in an individual simultaneously. In PKDL cases
sensation over the lesions is preserved in contrast to leprosy where similar lesions have no
sensations or less sensation. The skin lesions of PKDL do not ulcerate and self healing of the
lesions is not reported. Though PKDL is a rare condition (1 in 50-100 cases of Kala-azar) it is
24
epidemiologically important because they act as the main reservoir of infection. In PKDL cases
the parasite concentrates in the skin lesions and is readily available to the insect (Phlebotomus)
vector when it bites the patient.
The clinical manifestations of these dermal lesions may be of three types:
▪ Macular lesion: These are earliest dermal lesions. The usual sites of distribution of these
macules are the trunk and extremities; the face is less commonly affected. The loss of
pigmentation is not complete.
▪ Papular lesion: These are also early lesions, which appear on the nose, cheeks and chin,
often having a butterfly distribution (“butterfly erythema”). They are very photosensitive,
becoming prominent towards the middle of the day.
▪ Nodular lesion: These replace the earlier lesions and occasionally appear from the very
beginning. The nodules are generally found on the skin and rarely on the mucous membrane
of the tongue and eyes. They appear mostly on the face but may appear on any part of the
body. The absence of ulceration of the nodules is a characteristic feature of PKDL
2.6 Complications of Kala-azar:
1. Secondary infections:
Pneumonia
Pulmonary Tuberculosis
Amoebic or bacillary dysentery
Gastroenteritis
Herpes zoster
Chicken pox
Skin infection; boils, cellulitis, scabies
Cancrum Oris
Septicaemia
Otitis media
2. Bleeding manifestation – from nose, GIT, retina, etc.
3. Post Kala-azar Dermal Leishmaniasis (PKDL)
4. Post Kala-azar laryngitis and colitis.
25
5. Post Kala-azar splenomegaly
6. Renal
o Glomerulonephritis
o Nephrotic syndrome
7. Cirrhosis of liver
2.7 Complications of PKDL:
PKDL occasionally coexist with VL; other post Kala-azar manifestations such as post Kala-azar
mucosal leishmaniasis, uveitis, conjunctivitis, and blepharitis may be seen simultaneously in the
same patient. Similarly, involvement of the mucosal surfaces, in particular in the mouth and the
larynx, as well as eye involvement such as keratitis has also been described.
2.8 Laboratory Diagnosis of Kala–azar (annexure-2)
Diagnosis of Kala–azar may be possible by the following:
A. Indirect evidence or serological test (annexure 4)
B. Direct evidence or parasitological diagnosis
C. Others: Haematological and Biochemical changes in blood
Laboratory Diagnosis of Kala-azarLaboratory Diagnosis of KalaLaboratory Diagnosis of Kala --azarazar
Direct Evidences
(Demonstration of L. donovani)
Indirect Evidences
Peripheral
blood (thick
film)
Amastigote form
Blood culture ( N.
N. N. medium ) Promastigote form
Biopsy
material
obtained by
Serum testsBlood tests
Lymph node
puncture
Sternal or
iliac crest
puncture
(Marrow)
Aldehyde test –
positive after 3
months
Antimony test –
less reliableAntibody
detection
PCR detection
Spleen puncture
(Splenic pulp)
26
A. Indirect evidence
1 Rapid dipstick ‘rK-39’ test (ICT for Kala-azar)
The rapid dipstick ‘rK-39’test is the mainstay in the serological diagnosis of Kala-azar. It is
recommended for identifying the case of Kala-azar. (‘rK-39’ test may remain positive for 2 years
after completion of Kala-azar treatment)
1. a. How to perform the ‘rK-39’test
• Remove the test strip from the pouch or the vial
• With a Fresh lancet, prick the fingertip of the patient suspected to be suffering from Kala-
azar. Lancets should not be reused because of the risk of transmitting HIV and Hepatitis B
and C.
• Let the blood come out on its own. Do not use pressure or squeezing for obtaining blood.
• Place one drop of blood on the absorbent pad of the strip bottom.
• Place the test strip into a test tube so that the end of the strip is facing downwards. This
would encourage the blood to migrate upwards by capillary action.
• Add 2-3 drops of buffer solution provided with the kit to the pad.
• Read the results in 10 minutes. Do not read the results before or after 10 minutes.
1. b How to interpret the results
Positive result
A red line appears in the control area and another red line appears in test area where the blood has
migrated through capillary action. There should be two red lines for the test to be positive. A faint
red line also is to be considered positive.
Negative result
There is a red line in control area but there is no red line in test area where the blood has migrated
by capillary action at the end of 10 minutes.
Invalid test
There is no red line in control area or in the test area where the blood is to migrate by capillary
action. The test is also invalid if there is a red line in the test area but no red line in the control area
where the blood was initially placed.
27
Table 2 If the test is invalid it should be repeated following the correct procedure.
Control area (C) Test area (T) Interpretation
Red line Red line Positive
Red line No line Negative
No line Red line Invalid test
No line No line Invalid test
1. c. Storage and supply of ‘rK-39’ test strips
The test strips should be stored safely at room temperature between 20-30 degrees Celsius.
Temperature in excess of 30 degrees can reduce the quality of the test. The buffer solution should
be stored at 20 -80c. The test strips and the buffer should not be frozen since freezing deteriorates the
quality of the reagent. The strip should be taken out from the vial or the pouch only at the time of
performing the ‘rK-39’test. The strip should only be used within one hour of taking out from the
vial or the pouch.
It is not advisable to store large quantities of ‘rK-39’ in the peripheral locations where the
temperature can not be properly maintained as required in the specifications. The districts locations
(level II) should serve as the supply points for the peripheral units from where supplies can be made
once in a month or when the workers come for a review meeting.
1. d. Where should ‘rK-39’ test be done.
For the success of the elimination programme, it is necessary that ‘rK-39’ test is available to the
poor people in the locality/area. The programme manager should map the various facilities in the
public and private sector and identify the locations where the test is to be provided based on the
followings:
(a) The health workers can detect enlarged spleen;
(b) The facilities where treatment of Kala-azar is available;
(c) The distance of the facility from the community.
The test may be made available at the upazilla health complex (level 1) in the government
facilities. The programme manager in the district can decide about private and the NGO sectors
28
where similar facilities are available. The facilities in the private sector that should be considered
are hospitals and private laboratories. Facilities where there is willingness and interest in
participating in the programme should be selected as the sites for testing with ‘rK-39’.MOU may be
signed with the private sectors and NGOs. In the beginning of the programme, a few facilities
should be selected. After ensuring that the services provided are reliable, more facilities may be
included.
1. e. Advantages and limitations of ‘rK-39’ test
The pros and cons of ‘rk39’test in the diagnosis of Kala-azar are summarized in table.
Table 3 Pros and cons of ‘rK-39’test in the diagnosis of Kala-azar
Pros Cons
• Test can be performed with one
drop of blood drawn from a finger
tip.
• The result is obtained within 10
minutes
• The test can be performed in any
setting by a trained health worker
• ‘rK-39’test is reliable and compares
well with confirmatory tests
Therefore there is no need to
perform confirmatory tests in all
cases of Kala-azar
• The test is also positive in cases of
PKDL
• The rapid test ‘rK-39’ is positive in
95-100% patients of Kala-azar.
• Early cases can be detected.( the
test become positive after two
weeks)
• The test strips have to be stored at
recommended temperature and
humidity to maintain its reliability.
The test will lose its quality if
stored at temperature less than 20
and more than 30 degrees Celsius
for a long time (several months)
• It is not recommended in patients
who have HIV-Kala-azar co-
infections
• The test remains positive even after
cure of Kala-azar, so the test cannot
be used in patients who have a
relapse or a reinfection
• At present ‘rK-39’test is not
recommended to decide about the
cure from kala azar since the test
continues to be positive even after
the patient has clinically recovered
from the disease.
29
1. f. Training on ‘rK-39’ test
The training should be a part of plans for capacity development on diagnosis, treatment and
prevention of Kala-azar. The participants should include doctors, health workers and laboratory
technicians from the facilities selected in the government, private and NGO sectors. The subjects to
be covered in the training include (a) determining the quantities of ‘rK-39’ tests needed (b) safe
storage of the vials/pouch of ‘rK-39’ (c) Test procedure steps (d) and Interpretation of test results
(e) recording and (f) action to be taken in patients with a positive test. It is important that all the
health care providers who are expected to perform the ‘rK-39’ test are provided hands on training so
that they learn the correct procedures by doing the tests themselves.
2.9 Supportive supervision
Supportive supervision of the diagnosis of Kala-azar is an integral part of general health services in
the district. To ensure reliable diagnosis, supervision should be done for all facilities (i.e. in the
government, private and NGO sector) where ‘rK-39’test is done. Supervisor should use the check
list provided and prepare a written report of the findings and make recommendations for follow up
actions. The reports of the supervisory visits should be kept in the district office (Level II) and
reviewed by the district focal point regularly once in a month.
2.10 Quality assessment
Bangladesh should develop quality assurance protocol in order to sustain the reliability of ‘rK-39’
as a diagnostic tool. One reference laboratory is required for quality assurance. The reference
laboratories should have a network to maintain the highest standards in the diagnosis of Kala-azar.
Quality assessment includes the quality of various test kits that are being used on a regular basis.
This means testing of kits from the government facilities and those that are sold in the market. As a
part of quality assurance, at least 5% of the tests should be cross checked by PCR. This test can only
be done in specialized facility. The district staff should be responsible for cross checking a
proportion of positive and negative tests with standard.
30
Fig: 2 rK-39 test with positive and negative results
2.11 Rapid Diagnosis of Kala-azar:
The ‘rK-39’ test for kala–azar is very reliable test for diagnosis of Kala-azar in the field situation
and quick mass sero survey. Its sensitivity is ~100% and specificity (92.3% - 95%) is also
comparable to ELISA. So this test is considered for diagnosis of a Kala-azar at field situation.
However, as with all diagnostic tests result must be correlated with other clinical information
available to the physician.
2.12 Diagnosis of PKDL by ‘rK-39’ test:
Suspected patients of PKDL should be screened by ‘rK-39’ test. In cases of PKDL with only
macular lesions, the ‘rK-39’ test may be negative. These cases should be referred to a facility where
detection of the presence of the parasite can be done. The confirmatory diagnosis of PKDL can be
made by demonstration of the parasite (L.D.bodies) in the skin lesions by slit skin smear. The
31
nodular, papular or the macular lesion is slit and tissue fluid is then placed on a slide. The slide is
then stained (annexure 7) the same way as the bone marrow or splenic puncture aspirate. It is then
examined for LD bodies under the microscope. If smear is negative or inconclusive, then skin punch
biopsy should be done to detect the parasite.
If the above procedures fail to detect the parasite, then the patient should be tested by PCR for
identification of parasite. It is important to observe all safety precautions to prevent HIV/AIDS,
Hepatitis B and C and other blood borne infections while doing the scraping of the skin for the test.)
rK-39 Slit skin smear Skin punch biopsy PCR (annexure 9)
2. The other following serological tests are in current practice.
• Napier’s Aldehyde test
• Direct agglutination Test (DAT)
• Enzyme-Linked Immunosorbent Assay (ELISA)
• Indirect Fluorescent Antibody Test (IFAT)
• Counter-Immunoelectrophoresis (CIE)
• Latex Agglutition Test (LAT)
Napier’s Aldehyde test
Although widely used in the past, this test is not reliable and therefore not recommended for the
diagnosis of Kala-azar in the programme.
Direct agglutination test (DAT)
Although a useful test, DAT is not recommended for use in the programme for the following
reasons:
• Only one research laboratory is able to produce the reagents. There are variations in quality
and difficulties in standardization
• The test requires cold chain and storage at 40 Celsius
• Only trained staff can interpret the results correctly
• Requires laboratories with facilities for refrigeration, incubation and a stable power supply
• The results cannot be provided on the same day
32
3. Hematological change:
Anemia
Raised erythrocyte sedimentation rate (ESR)
Leucopenia: Neutropenia with relative lymphocytosis & monocytosis.
Thrombocytopenia
4. Biochemical investigation (According to need)
Serum Bilirubin
SGOT, SGPT
Serum Albumin
Serum Globulin
Urea, Creatinine
B. Direct evidence
a) Demonstration of parasites is the most conclusive evidence in the diagnosis of Kala-azar and
PKDL, Parasites are detected by microscopic examination of smear prepared from:
Bone marrow
Splenic aspirates
Buffy coat
Liver biopsy
Lymph node biopsy
Skin lesions
b) Culture of the biopsy material in different media like N.N.N media, Eagle’s media etc. for
isolation of parasite.
c) PCR for DNA detection of L.D from the peripheral blood and tissue
33
2.13 Bone marrow examination for amastigote of L.D bodies (annex-5)
2.14 Splenic aspiration for amastigote of L.D bodies (annex-6)
2.15 Diagnosis of Kala-azar in special situations
The diagnosis of kala-azar can be difficult in special situations. These include the following:
• Kala –azar HIV co-infection
• Kala-azar in pregnancy
• PKDL with macular lesions
In cases of Kala-azar HIV co-infections and in cases of PKDL with only macular lesions the ‘rK-
39’test may be negative. In Kala-azar HIV co- infection the diagnosis can be confirmed by bone
marrow examination or splenic aspiration in Level III facilities. If both tests are negative or
inconclusive, then patient should be sent to specialized laboratory for PCR identification. In PKDL
with macular lesion, the diagnosis is made from the slit skin smear or a skin punch biopsy in level
III facilities. If the slit skin or biopsy is negative or inconclusive, the patient should be tested for
PCR identification. Patients with Kala-azar in special situations should be referred to the required
level of facility as appropriate.
Kala-azar HIV co-infection:
rK-39 Bone marrow / Splenic aspirate PCR
Kala-azar in pregnancy:
rK-39 PCR
PKDL with macular lesions only:
Slit skin smear Skin punch biopsy PCR
2.16 Clinical Case Definitions of Kala-azar & PKDL:
There are three case definitions: Kala-azar (KA), Kala-azar Treatment Failure (KATF) and Post
Kala-azar Dermal Leishmaniasis (PKDL)
34
Kala-azar (KA)
Fever or History of fever for 2 weeks or more:
1. Irregular pattern of fever
And
Splenomegaly
And
2. High index of suspicion based on residing/ traveling in endemic area
And
3. Absence of convincing evidence of any other febrile illness
And
rK-39 test positive
A Case of kala –azar: An individual in an endemic area who has fever for more than 2
weeks, splenomegaly and ‘rK-39’test is positive should be diagnosed as a case of Kala-
azar.
35
Kala-azar Treatment Failure (KATF)
1. Earlier: diagnosed as Kala-azar
And
2. Took complete treatment
And
3. Again features of Kala-azar
And
4. Any positive lab evidence: Bone Marrow (BM) / Splenic aspiration (SA)
And
5. Period: Within one year
Post Kala-azar Dermal Leishmaniasis (PKDL)
1. Multiple hypo pigmented areas on skin without loss of sensation
With or Without
2. Any one or combination or all
a) macule
b) papule
c) nodule
d) history of Kala-azar
And
3. High index of suspicion based on residing/traveling in endemic area.
And
4. rK-39 positive
36
2.17 Case Definitions for Reporting:
1. Suspected Kala-azar: Patients with fever (of more than 2 weeks) from an endemic area who has
one or more of the features –1) splenomegaly, 2) anaemia and 3) weight loss
2. Confirmed Kala-azar: When the suspected case is confirmed by positive rk39 or demonstration
of parasite in the tissue (BM/SP) or by PCR.
3. Kala-azar Treatment failure (KATF)
4. PKDL
When reporting the ‘reporting case definition’ term will be added as a prefix to the ‘clinical case
definition’ term of Kala-azar categorized as per national guidelines.
2.18 Differential diagnosis
The following common differential diagnosis should be ruled out considering their frequency in
Bangladesh. The indicators of differential diagnosis are mainly: prolong fever, splenomegaly,
hepatomegaly, progressive weight loss, emaciation, skin changes and opportunistic infection.
1. Malaria
2. Leukemia
3. Lymphoma
4. CLD
5. Carcinoma of liver
6. Portal hypertension
7. CCF
8. Hemolytic anemia
9. Tuberculosis
10. Leprosy (for PKDL)
11.Storage disease
Example
A case is found to be KA as per clinical case definition. For reporting purpose this
will be labeled as ‘Suspected KA’. If rK-39 test is found positive or if parasite is
demonstrable in any tissue exam test e.g BM, SP then the case will be ‘Confirmed
KA’
37
Locations where diagnosis of Kala-azar should be offered:
As mentioned earlier, the programme should map out the facilities in the district to make the
locations where the diagnosis is available and it should be known to the people through behaviour
change communication.
Table 4 Location for Kala-azar diagnosis
38
A) Level 1
In endemic areas in union (subcentre or others)
1. Identify cases of fever of more than 2 weeks duration
2. Identify cases who have macular, papular or nodular skin lesions but no other signs
3. Refer the patients with above problems to Upazilla health complex for evaluation,
testing and treatment for Kala-azar or PKDL.
In endemic areas in upazilla health complex
1. Check patients with fever of more than 2 weeks associated with splenomegaly
2. Check patients with macular, nodular or mixed lesions without loss of sensation.
Perform ‘rK-39’ test :
(a) On all patients with fever of more than 2 weeks and have splenomegaly
(b) Patients with macular, papular or nodular or mixed lesions and no loss of sensation.
3.Treat patients of kala-azar with first line drugs
4. refer all cases of PKDL and unresponsive cases of Kala-azar to level III facility
B) Level II
1. Check patients with fever of more than 2 weeks associated with splenomegaly.
2. Check patients with macular, nodular or mixed lesions without loss of sensation.
Perform ‘rK-39’ test :
(a) On all patients with fever of more than 2 weeks and have splenomegaly
(b) Patients with macular or nodular or mixed lesions and no loss of sensation.
3. Treat patients of kala-azar with first line drugs
4. Refer PKDL cases to level III facility.
C) Level III
1. Treat unresponsive or resistant? Kala-azar cases and PKDL cases
2. Perform the slit skin smear/biopsy in suspected cases of PKDL that are ‘rK-39’test
negative
3. Perform bone marrow /splenic aspiration in patients where these are indicated, as a part
of drug monitoring studies or as a part of quality assessment
4. Treat any complications associated with bone marrow/splenic aspirate
D) Level IV (specialized laboratories)
1. Perform PCR test for establishing the diagnosis of PKDL in cases that are suspected to
have the disease but ‘rK-39’test is negative
2. Diagnosis of HIV-Kala-azar coinfection may be done by bone marrow/splenic aspirate
39
Learning unit 3:
TREATMENT OF KALA-AZAR and PKDL
Content:
Treatment: KA
1st line treatment
2nd line treatment
Treatment in special situations: Pregnancy, Co morbidity (Pneumonia, HIV,
Tuberculosis)
Treatment of complications:
Treatment of PKDL
Brief description on individual drug with adverse events
Management at different levels
Terms/ Criteria for referral, referral format
Management of adverse events
Pharmaco-vigilance
Treatment flowsheet/chart
Objective: at the end of the session the participant will be able
to
• mention the Treatment of KA and PKDL
• identify the AE of treatment
• mention the treatment of adverse events
• recognize the patient to refer
• describe the management at different levels
• enumerate pharmaco-vigilance
• illustrate the treatment flowchart
40
TREATMENT OF KALA-AZAR and PKDL
The objective of treatment for Kala-azar is to cure the patient, prevent the complications of the
disease and minimize side effects of medicines, contain drug resistance and reduce the risk of
spread of disease.
This can be achieved by complete treatment and monitoring. Other symptoms/diseases in patients of
Kala-azar should also be diagnosed and treated. Appropriate drug with recommended dose and
duration should be given to a patient of Kala-azar.
3.1 Drug treatment of Kala-azar: (annexure 10 &11)
3.1.1 Treatment – A (Oral Miltefosine) 1st line of treatment for Kala-azar patients
Miltefosine:
Miltefosine is a relatively safe oral drug for the treatment of Kala-azar. It is now recommended for
use in Bangladesh.
Miltefosine, a membrane-active alkyl phospholipid developed as an antineoplastic agent and now
also used topically in breast cancer skin metastases has been shown to be active against Leishmania
in various animal and human models. It is an oral antiprotozoal agent, which has marked direct anti-
Leishmanial activity both in vitro and in vivo. Though the mode of action of Miltefosine is not
clearly known, it may act through inhibition of phospholipid metabolism.
Miltefosine is well absorbed from the gastrointestinal tract and is widely distributed in the human
body. The plasma concentrations were roughly proportional to the dose in the range of 50-150
mg/day. The maximum serum concentration ranges from 24-82 g/ml with tmax of 23 days. No
relevant sex difference of the pharmacokinetic parameters have been observed. Miltefosine does not
show oxidative metabolism by the cytochrome P450 enzyme system.
41
When to avoid the use of miltefosine:
Miltefosine is the preferred first line of drug in all patients of Kala-azar except in the followings:
• Women during pregnancy
• Married women of child bearing age who are not using contraceptives regularly and are at
risk of becoming pregnant
• Women who are breast feeding.
• Infants
Miltefosine may not be the ideal drug for patients of Kala-azar with severe under nutrition, severe
anaemia and patients with known history of kidney or liver disease
Recommended dose schedule:
Dose: 2.5mg/kg body weight, in two divided dose by mouth in the morning and evening after
meal for 28 days.
In case of missed doses, the scheduled 28 doses may be taken within a period of 35 days. The daily
dose should never exceed the recommended amount.
The doses should be calculated as follows:
i) >12 years and weighing ≥25kg: 100 mg. (cap 50 mg in morning and 50 mg in
evening)
ii) >12 years but weighing <25kg: 50 mg. (cap 50 mg in the morning)
iii) 2-12 years: 2.5 mg/kg body weight. ( in two divided dose, not exceeding
50mg/day)
If an exact dose cannot be administered, the closest 10 mg increment will be chosen at the dose.
Rounding will be done as follows:
❖ If the calculation comes to <5 – to round dose down.
❖ If the calculation comes to >5 – to round the dose up.
Before starting Miltefosine in Kala-azar patients with severe anaemia and severe malnutrition,
anaemia should be corrected by blood transfusion and malnutrition by appropriate feeding. If
dehydration is present, it should be corrected before starting miltefosine. Married women of
childbearing age should not be given Miltefosine, if the couple does not agree to use suitable
contraceptive methods to prevent pregnancy during treatment and two months thereafter.
Adverse reaction and their treatment:
Adverse reactions to Miltefosine are mostly mild. Mild to moderate vomiting is seen in 40%
patients and mild diarrhea in 15-20% patients. These usually occur during first week of treatment.
42
The patient should be advised to take sips of oral rehydration salt solution (or any other liquid if
ORS is not available) frequently. If vomiting does not stop, despite the use of ORS, the patient
should be referred to a hospital (Upazilla health complex or level II) for IV fluid administration.
Diarrhoea is usually self limiting. Additional antibiotic is generally not recommended. In few cases,
there may be skin rash and hepatotoxicity and nephrotoxicity. Hepatotoxicity is evidenced by
jaundice and nephrotoxicity is evidenced by puffiness of face or decreased urinary volume
(oliguria/anuria). If any of these symptoms are reported the patient should be referred to level II
facility for advice and treatment.
Duration of treatment:
Miltefosine should be given daily for 28 days. In case of missed doses treatment up to 35 days is
recommended to complete the full course.
3.1.2 Treatment –B (Sodium Antimony Gluconate) for Kala-azar Treatment failure cases with
Miltefosine and when Miltefosine is not available
Treatment B is described in the Kala-azar Treatment Chart for the treatment of Kala-azar cases who
did not respond to Miltefosine and when Miltefosine is not available.. The drug of choice is Sodium
Antimony Gluconate (SAG) 100mg/ml. SAG should be given at a dosage of 20mg/kg body weight,
daily IM injection for 30 days. It is essential to weigh the patient every time before starting a new
cycle.
Route of Administration of SAG:
The preferred route of administration recommended by WHO is deep intramuscular (IM). It is better
not to give the drug intravenously (I/V) to avoid the risk of cardiovascular collapse. After each
injection keep the patient lying on the bed under observation for at least half an hour because of the
risk of hypo tension and syncope. Unused reconstituted drug should be discarded within 24 hours of
preparation.
Adverse events of Sodium Antimony Gluconate treatment:
In clinical practice of therapy with SAG, minor side effects are common, moderate side effects are
uncommon and severe side effects very rare. The commonest adverse events are pain at the
injection site, muscle pain (myalgia), joint pain (arthralgia), loss of appetite nausea and increased
43
transaminase level. These symptoms are relatively mild and myalgia & arthralgia may be controlled
by paracetamol. QT segment changes (prolong QTc> 0.5 msec, T inversion) may occur on the ECG,
and therefore in ideal circumstances ECG monitoring before treatment and weekly during treatment
should be performed. Clinically important arrhythmias (ventricular ectopics, ventricular Tachy
cardia, Torsades de points, ventricular fibrillation) or heart failure are very unusual, but if occur
may cause sudden death. In ideal circumstances weekly monitoring of hepatic and renal function
and estimation of amylase should be undertaken, though these rarely give rise to symptomatic
illness.
There is no absolute contra-indication to pentavalent antimony treatment, and even severely ill
patients should respond. Pentavalent antimony is not contra-indicated in pregnancy. If underlying
cardiac, renal or hepatic disease is present, the patient should ideally be carefully monitored during
treatment and other drugs should be considered.
Since alternate relatively safe drugs are now available, SAG should be phased out from the national
programme.
3.1.3. Treatment C – Amphotericin-B deoxycholate or liposomal Amphotericin 2nd line of
treatment for Kala-azar:
Recommended second line drugs for treatment of Kala-azar are Amphotericin B and liposomal
amphotericinB. The second line of drugs are recommended in the following conditions:
• Patients not responding to the first line of drug or the drug was discontinued due to toxic
effect.
• Women during pregnancy
• Women who are breast feeding their babies
• Infants less than 2 year.
• Kala-azar patient with liver or kidney disease.
Amphotericin B:
• Amphotericin B deoxycholate 1 mg/kg daily is recommended in the form of daily IV
infusion (in 5% Dextrose solution) for 20 days having a cure rate of >90%. Skin test should
be done before administration of Amphotericin B. The infusion should be given slowly over
a period of 6 hours.
44
• Adverse events: In some cases, there may be infusion releted side effects like fever with
chills and rigors and thrombophlebitis. Generally these can be controlled by paracetamol and
anti histaminics. Rarely hydrocortisone may be required.
• Rarely there may be severe adverse events like renal or hepatic toxicity hypokalaemia, and
myocarditis and thrombocytopenia.
• Amphotericin B should be administered by admitting a patient in a hospital during the entire
period of treatment for close supervision and monitoring of side effects.
Liposomal amphotericin B:
• To improve the tolerance and widen the narrow therapeutic window, a lipid formulation of
Amphotericin B is formulated. Amongst the three formulations liposomal Amphotericin B
has the best safety profile.
• Liposomal amphotericin B is given IV in a dose of 3mg/kg for 5 days. It is safe, has no side
effects with a cure rate > 95%.
3.1.4 Treatment D (Sodium Antimony Gluconate) for PKDL cases
Treatment D is described in the Kala-azar Treatment Chart for the treatment of PKDL cases only.
The drug of choice is Sodium Antimony Gluconate (SAG) 100mg/ml. SAG should be given at a
dosage of 20-mg/kg/day in intramuscular route. It is essential to weight the patient every time
before starting a new cycle. Total 6 cycles of treatment should be given. Each cycle consists of 20
days of treatment and there should be an interval of 10 days in between two cycles.
Other treatment options of PKDL cases
Other treatment options of PKDL cases are liposomal Amphotericin, AmphotericinB and Miltefosine.
Longer duration of Miltefosine (4 wk, 8 wk & 12 wk) are being used for treatment of PKDL in India. Amphotericin-B Dose: 1 mg/kg body wt daily IV (in 5%Dextrose solution) for 15 days. Six cycles with 10 days
interval between cycles Route: IV c) Amphotericin B (Liposomal)Dose: 3mg/kg/day Route: IV Duration: 5 days, six
cycles with 10 days interval between cycles.
3.1.5 Newer drugs- Paromomycin:
Paromomycin is a promising new effective drug. It has been registered for use in India.
45
• The recommended dose is 15 mg/kg/day to be given IM for 21 days.
• The total estimated cost per treatment of the drug is about 10 US Dollars.
• The medicine is safe with minimal ototoxicity or nephrotoxicity. In the recommended dose
the ototoxicity is reversible.
• Paromomycin should be avoided in patients with severe anaemia with hemoglobin <5 g/dl.
• Pain in injection site is common.
3.2 Complete Treatment of Kala-azar:
Patients of Kala-azar must complete treatment in the right dose without any interruption if a cure is
to be achieved. All efforts should be made to ensure the complete treatment. The following
measures are recommended to complete the treatment:
• Counsel the patient so that the patient/family fully understands why it is important to take
complete treatment. Explain the consequences if the treatment is not taken as advised.
• It is important to tell the patient, the family and the community that the premature
discontinuation of the treatment would be the reason for continued risk of spread of the
disease to others.
• All treatment is provided free of cost. So economic constraints should not be a reason for
discontinuation of treatment and
• Each patient should have a separate treatment box that contains the full 28 days (for
Miltefosine) treatment. The treatment box should have the name and individual
identification of the patient.
• It is advisable to give the medicine supplies for a period of 3 days initially so that if the
patient has any problems a check up is done in the health center/hospital and treatment is
provided for the side effects if required.
• Use treatment card with a unique identification number. The card shows the number of days
the treatment has been taken by the patient.
• The treatment of Kala-azar should be done under observation of the health care provider. So
any side effects or compliance or reinforcement can be ensured.
• There should be coordination amongst the public sector and private providers and a follow
up plan should be developed for each patient so that there is no interruption of treatment.
46
• The patient usually begins to feel better after a few days of starting the treatment but should
be told that cure would occur only when full treatment has been taken..
• The patient may discontinue the treatment because of the side effects of the medicine. The
patient should be advised to contact the health worker as soon as a problem is detected. The
health worker should treat the side effects and reassure the patient so that the treatment is
not discontinued. If improvement does not occur, the patient should be referred to the
hospital (Upzilla health complex at level I or level II )
3.3. Pharmaco-vigilance:
Pharmaco vigilance is important to ensure the safety of the medicines used in the treatment of Kala-
azar. It should be the responsibility of the national programme to ensure pharmacovogilance. The
programme can provide very useful information but unless protocols are appropriate and the
supervision is strong the quality of information may be compromised.
Each medicine used in the programme has some side effects. These may be looked for in the form
of signs and symptoms. Laboratory tests can help to recognize the occurrence of the side effects
early. Although tests like haemogram, liver and kidney function tests, electrolytes and ECG are
recommended to monitor the patient, the inclusion of these tests in the programme is difficult. This
information can be complemented by regular reporting of major and minor adverse events. The
following measures will help to recognize early the occurrence of adverse events.
• Monitor the patient regularly for signs and symptoms (indicative of adverse events of
drugs). These signs and symptoms should be classified as major and minor.
• Perform the tests if possible in treatment sites and monitor the results. This can help to take
timely measures even before the signs appear.
• Periodic meetings should be organized to review the reports of major and minor adverse
events obtained from the different levels. This will help guide the programme in
recommending the tests that should be done to monitor the patients on treatment.
• Regularly report the adverse events on the reporting formats to higher levels once in a month
for a review and feedback
47
Table 5 Adverse events and laboratory test used
Medicine Side effects Laboratory tests
Miltefosine Vomiting, Diarrhoea, Abdominal
pain (minor)
Persistent vomiting, Dehydration
(major)
Oedema, decreased urine, jaundice
(major)
Fatal nephro/hepato toxicity in
about 1% cases
Complete blood
counts
Electrolytes
Liver and kidney
function tests
SAG Arthralgia, myalgia (minor)
Arryhthmias, heart failure (major)
Oedema, decreased urine (major)
Jaundice (Major)
Electrolytes
ECG
Renal functions
Liver functions
Amphotericin B Fever with chills and rigors (major)
Severe vomiting, dehydration
(major)
Oedema, decreased urine output
Arrhythmias (major)
Electrolytes
Renal functions
ECG
Other drugs can be added to the list based on the national drug policy and approval by technical
advisory committee e.g. paromomycin
3.4 Treatment of Kala-azar in special situations:
The treatment of Kala-azar in special situations is recommended in centers where appropriate
expertise and facilities are available. The following conditions can be considered as special
situations:
• Pregnancy
• Married women of reproductive age who are not using contraceptives regularly
• Women who are breast feeding their babies
• Infants
48
• Kala-azar with severe anaemia (Haemoglobin less than 5 g/dl)
• Kala-azar with TB
• Kala-azar HIV coinfection or kala azar and AIDS
• Kala-azar in a patient suffering from another serious disease
3.4.1 Kala-azar in Pregnancy:
Vertical transmission of Kala-azar is possible and the instituation of treatment is imperative in cases
of pregnant women with Kala-azar. Amphotericin B is recommended as the drug of first choice. It
is reasonably safe in the mother and foetus. US Food and Drug Administration consider liposomal
Amphotericin B in pregnancy category B. Miltefosine is contra-indicated. Antimoy containing
drugs have reproductive toxicity and mutagenic and oncogenic potential, though the risk is low.
3.4.2. Kala-azar in women who are breast feeding their babies:
The choice is between amphotericin B and liposomal amphotericin B. Miltefosine is
contraindicated.
3.4.3. Kala-azar in married women in reproductive age not on contraceptives:
Miltfosine can be used in these patients but before initiating miltefosine, a long acting
contraceptive should be given. The contraceptive should be effective in averting pregnancy for at
least 2 months after completion of treatment.
3.4.4. Kala-azar with severe anaemia:
Anemia should be corrected by blood transfusion and /or supplementation of iron and folic acid
before specific treatment started. If this seems to delay the treatment and the patient has severe
Kala-azar then it is advisable to treat the patient with amphotericin B or liposomal amphotericin B.
Similarly nutritional status of the patient should be improved before administration of specific
treatment. This treatment is available in level II and level III facilities.
3.4.5. Kala-azar HIV co-infection:
Level II facilities cannot check the HIV status. However, level II facilities can suspect the
coinfection based on the risk profile of the patient (FSW, MSM or an IDU). It is also possible to
treat the opportunistic infections related to HIV and treat Kala-azar in level II facilities. If HIV is
49
suspected because of the risk profile or HIV status is known the patient should be referred to a
facility where the HIV status can be checked and facilities are available to provide ART. Since the
‘rK-39’ test may not be positive in patients who have HIV it is necessary to refer such patients with
coinfection to a facility where the parasitological diagnosis can be made.
Guidelines for treatment and care are to be provided jointly by National programmes for Kala-azar
elimination and the national AIDS control programme. These programmes should have
collaboration to effectively deal with the Kala-azar HIV confection. The key steps in the diagnosis
and treatment of HIV Kala-azar coinfection are summarized in the diagram. The details are outside
the scope of these guidelines. Response to SAG, Amphotericin B is far from satisfactory.
Miltefosine has been found to be promising.
Figure 3
PeripheralPeripheral BloodBlood//UrineUrine
rk39 k39 KAtexKAtex PCRPCR
65% 8765% 87--100% 72100% 72--100%100%
POSITIVE
TREATMENT
NEGATIVE
BM/BM/SpleenSpleen AspirateAspirate
MIC CULTMIC CULT PCR PCR
6767--94% 5094% 50--100% 82100% 82--100%100%
VL NEGATIVE
NEGATIVE
DiagnosticDiagnostic atat primeattackprimeattack in in
LeishmaniaLeishmania--HIV HIV coco--infectioninfection
3.4.6. Kala-azar TB co-infection:
The treatment of this co-infection requires treatment of TB with DOTS and of Kala-azar
as per the national guidelines. If there are any complications then the treatment may have
to be done in level III or specialized facilities.
50
3.5. Treatment of Kala-azar at different levels of health facilities
The facilities referred to in the table can be in the government sector, private sector or
NGOs.
Table 6 Kala-azar treatment in different health facilities
Level I at union level:
• Suspect cases of Kala-azar and PKDL and refer them for diagnosis and treatment to upazilla
Health complex
• Educate and convince the patient to complete the treatment as advised
• Follow up the cases of Kala-azar
• Observe for vomiting, diarrhea or abdominal pain and for any other severe sign like jaundice,
oedema or decline in the volume of urine passed. If any of these are detected, stop the
treatment immediately. Refer cases e.g. severe vomiting, severe diarrhea, jaundice, oedema or
decline in the volume of urine immediately
• Treat vomiting/diarrhea with ORS or home available fluids. Refer patients to level I upazilla
health complex who do not improve.
Level I at Upazilla health complex:
• Treat cases with Miltefosine. Ensure availability of effective contraceptives for three months
to women at child bearing age that could get miltefosine. Refer cases who cannot be treated
with miltefosine to level II facilities.
• Registrar and fill treatment cards and update them
• Prepare the patient for treatment by treating anaemia and give nutiritonal guidance for
undernutrition. Treat dehydration before the patient is started on specific medicines for Kala-
azar
• Provide written guidance to the health worker for follow up and observation.
• Advise patients on treatment to report as soon as any side effects are observed.
• Refer the PKDL cases to levelIII
• Report to level II facilities on kala azar patients once in a month
Level II
• Treat cases with Miltefosine. Ensure availability of effective contraceptives for three months
to women at child bearing age that could get miltefosine. Refer cases who cannot be treated
with miltefosine or SAG to level III facilities.
• Until miltefosine is available treat cases of Kala-azar with SAG.
• Patients on Miltefosine or SAG who are referred from government or private facilities for side
effects should be hospitalized for treatment.
• Refer cases to level III if SAG fails and Miltefosine is not available. Non responsive patients,
patients of Kala-azar who have an associated disease that can not be managed at level II
facilities should also be referred.. All cases of PKDL cases suspected to be suffering from
HIV Kala-azar coinfection should be referred to level III facility.
• Supervise the staff working in level I facilities
• Report once a month all information (include reports from all level I facilities) to the level III
51
Level III
• Treat cases of Kala-azar referred from level II facilities with alternative drugs. These include
pregnant women, married women in child bearing age who are not taking regular
contraceptives, patients who do not respond to medicines given in level II facilities, patients
with severe disease (severe anaemia, severe under nutrition, kidney or liver disease) and
patients with complications and side effects of medicine.
• Parasitological diagnosis is recommended before starting the treatment if the patient requires
admission.
• Treat hospitalized cases of Kala-azar who need be treated with Amphotericin B or Liposomal
amphotericin B.
• Treat uncomplicated cases of Kala-azar who are self referred with Miltefosine (or SAG if
miltefosine is not available) as an outpatient.
• Treat cases of PKDL and Complicated cases.
• Treat cases of Kala-azar HIV coinfections.
• Report once a month to the National programme.
Specialized facilities
• Ensure drug quality and maintain quality assurance of rK-39 by PCR.
• PCR testing for diagnosis in special cases.
• Study and research on developing new drugs.
• Report to the national programme once in a month.
52
Learning unit 4:
KALA-AZAR SURVEILLANCE AND REPORTING SYSTEM
Contents
• Background and introduction
• Reporting system
• Reporting format
• Reporting- data flow
• Report review and feedback
• Reporting of treatment, hospitalized cases
• Surveillance of Kala-azar and PKDL- passive surveillance, Active surveillance and
sentinel surveillance
Objective: at the end of the session the participant will be able
to
• describe the background and introduction
• describe the reporting system for KA/PKDL
• mention the reporting format
• describe the data flow
• mention review and feedback of Kala-azar
• describe the reporting of treatment and
hospitalized cases
• to enumerate passive surveillance, sentinel
surveillance,
• enumerate options of surveillance, PKDL
53
4.1 Background and Introduction
Disease surveillance is a key component of Kala-azar elimination program. It comprises of passive
and active surveillance of Kala-azar cases and vector surveillance. Vector surveillance is described
in another chapter (5.6 p-78). Surveillance includes reporting of all cases of Kala-azar and PKDL.
To make the disease surveillance effective, it would be necessary to organize a system of regular
reporting, analysis, review and feedback of information. Regular reporting and exchange of
information should be organized upwards, downwards and laterally in the system that comprises of
government, private sector, NGOs and the community as partners. Feedback is a part of supportive
supervision that is a critical element of the elimination program. It should be linked to surveillance.
Surveillance should also be used for sharing of reports periodically to higher authorities on a regular
basis to facilitate and rationalize the planning of elimination program. Surveillance is useful in
planning indoor residual survey through mapping of the areas to be sprayed and in monitoring the
trends of Kala-azar.
4.2 Reporting System
Reporting system comprises of mapping and identification of reporting units, development of
reporting formats, regular transmission of data, analysis of data, review and feedback.
4.2.1 Reporting units
There will be Kala-azar surveillance units at Upazila, District and National levels. The proposed
units are as follows
Proposed Kala-azar Surveillance Units
Upazila Kala-azar Surveillance Unit
• Head: UHFPO
• Focal Person: MO (Kala-azar Elimination)
• Statistical Assistant
District Kala-azar Surveillance Unit:
• Head: Civil Surgeon
• Focal Person: MO (CS/DC)
• Statistician
54
National Kala-azar Surveillance Centre
• Designated Institute: IEDCR
• Head: Director, IEDCR
• Focal Departments:
• Department of Parasitology
• Department of Epidemiology
• Department of Entomology
• Statistical Support: Analyst, Statistical Assistant
The “Upazila Health and Family Planning Officer” should take measures for developing reporting
system at the village/and union level with community participation. “Kala-azar Awareness
Meetings” should be held at Community Clinics/Upazila Health Complex, schools or other offices
of the local administration. A one-day training should be organized for by trained doctors at Upazila
level for domiciliary health and family planning workers and ‘Health Volunteers (HV)’ on how to
identify a ‘suspected case’ of Kala-azar or PKDL to refer the patient to the Upazilla Health
Complex where rK-39 test will be performed to confirm the diagnosis. The “health volunteers”
(HV) may consist of medicine sellers, traditional healers, etc.
Flow Chart for KA and PKDL Detection from Community
Identification & listing of the Health Volunteers
Training of the HV at Upazila Health Complex
Distribution of Referral forms among the HV
Monitoring HV activities and collection of Referral forms monthly
Monthly reporting surveillance data among partners
Evaluation of VHV activities quarterly
55
Upazila Kala-azar Surveillance Unit
The reporting unit will consist of UHFPO, MO (Kala-azar Elimination) and Statistical Assistant.
The doctors of Upazila Health Complex, Private Clinics or Nursing Homes, and Private
Practitioners should be integral part of this unit for reporting confirmed cases of Kala-azar and
PKDL. The Upazila Health Complex will receive suspected KA and PKDL patients from
community, health service facilities of union and level below and from OPD and IPD of UHC.
There will be a Kala-azar register with the MO (KA Elimination). After detection, the KA and
PKDL cases will be recorded in the KA register. The Statistical Assistant will enter the data in the
computer. The data should be entered in the monthly disease reporting form. A compiled report
will be sent monthly to the District Kala-azar Surveillance Unit through hard copy or internet (if
available).
District Kala-azar Surveillance Unit
The reporting unit will consist of CS, MO (DC/CS) and Statistician. The District Kala-azar
Surveillance Unit will receive compiled data of KA and PKDL patients from the UHC and from the
OPD and IPD of Medical College Hospitals and Sadar Hospitals under its jurisdiction. There will be
Kala-azar register with the designated MO (KA Elimination). The Statistician will enter the data in
the computer. A compiled report will be sent monthly to the National Kala-azar Surveillance
Centre. Reports will be sent downwards to reporting units.
National Kala-azar Surveillance Centre
The national disease surveillance centre (IEDCR) will be the National Kala-azar Surveillance
Centre. It will receive data from the district monthly. After compilation necessary data analysis will
be done here. Reports will be sent to Director (DC), Director (MIS) and downwards to the reporting
units.
4.2.2 Reporting format for diagnosis of Kala-azar and PKDL
All reporting units are expected to enter the information in the reporting format. A prototype format
is summarized in the table.
56
Table 7 Reporting format for diagnosis of Kala-azar and PKDL
Content Level I
(Upazila)
Level II
(District)
Level III
(National)
Number of patients of Kala-azar diagnosed
on the basis of clinical case definition and
positive ‘rK-39’ test
Number of patients of PKDL diagnosed on
the basis of clinical case definition and
positive ‘rK-39’ test
Number of patients of Kala-azar diagnosed
by a parasitic diagnosis (bone marrow or
splenic aspirate examination)
Number of patients of PKDL diagnosed by
parasitological diagnosis from a skin biopsy
or scrapings
Table 8 Reporting format for treatment of Kala-azar
Content Level I
(Upazila)
Level II
(District)
Level III
(National)
Number of patients recruited for treatment
with Miltefosine
Number of patients completing treatment
with Miltefosine
Number of patients where treatment with
miltefosine was discontinued
Number of patients recruited for treatment with
Amphotericin B
Number of patients completing treatment
with Amphotericin B
Number of patients where treatment with
amphotericin B was discontinued
Number of patients recruited for treatment
with Liposomal amphotericin B
Number of patients completing treatment
with Liposomal amphotericin B
Number of patients where liposomal
amphotericin B was discontinued
Number of patients recruited for treatment
with SSG
Number of patients completing treatment
with SSG
Number of patients where SSG was
discontinued because of complications
Number of patients where SSG was
discontinued because of side effects of SSG
57
Table 9 Reporting format for treatment of PKDL
Content Level I
(Upazila)
Level II
(District)
Level III
(National)
Number of patients recruited for treatment
with Miltefosine
Number of patients completing treatment
with Miltefosine
Number of patients in whom miltefosine
was discontinued because of side effects
Number of patients recruited for treatment
with Amphotericin B
Number of patients completing treatment
with Amphotericin B
Number of patients in whom amphotericin
B had to be discontinued because of side
effects
Number of patients recruited for treatment
with Liposomal amphotericin B
Number of patients completing treatment
with liposomal amphotericin B
Number of patients in whom liposomal
amphotericin B had to be discontinued
because of side effects
Number of patients of PKDL recruited for
treatment with SSG
Number of patients of PKDL who complete
treatment with SSG
Number of patients of PKDL in whom SSG
had to be discontinued because of side
effects
4.2.3 Reporting of information
The Upazila Kala-azar surveillance unit should send complete information on Kala-azar and PKDL
to the district focal point once in a month before the first Wednesday of each month. If there are no
cases then it should be a zero report. A zero report is as important as a report which enumerates the
cases seen but ‘no report’ is of no use. Absence of report will not lead to the conclusion that there
was no case. The data should be compiled at each level for the government, private and NGO
facilities. These should be exchanged between government, private and NGO facilities to develop a
common understanding of the problems. The reports after compilation should be submitted to the
MO (Kala-azar elimination) of the UHC. The statistical Assistant will compile information from all
the reporting units from the government, private and NGO facilities and add their own. The
58
consolidated report should be sent to the district. The data covers information for the preceding
month. In the district, the information from each reporting facility should be entered on the
computer and mapping done to identify the hot spots of Kala-azar in the district. The information
flow is summarized in the illustration.
59
Data Flow
Kala-azar Elimination Surveillance
First Contact Point
H&FWC,
Union Sub
Centre
NGO Health
Centre Private Health
Care Providers
Level I:
Upazilla KA Surveillance Unit
OPD of
UHC IPD of UHC
Level II:
District KA Surveillance Unit
Central Level:
National KA Surveillance Centre
MIS Director, DC
PM, Kala-azar
Division
Medical College
Hospital
Sadar Hospital
OPD/IPD
Health Worker/
FP Worker
60
Figure 4
Patient
card
Level 1
Monthly report
Level 2
Monthly report
Level 3
Monthly report
Patient
card
Patient
card
Program Manager
Patient
register
Drug
register
Drug
register
Patient
register
Patient
register
Indent
Indent
IndentDrug
register
Revie
wm
eetin
gs
Information flow
4.2.4 Report review and feedback
The district focal point and the supervisors have the responsibility to provide a regular feedback to
providers in UHC (government, private and NGO) on a regular basis verbally and follow up advice
in written. Review and feedback are important at all level. The staff of UHC should review with
field staff and other stake holders of the community reporting kala-azar & PKDL as a part of
supportive supervision regularly. All reviews and supervisory visits should be summarized and the
reports submitted to the district focal point.
The monthly reports along with the comments of the district focal point have to be sent to the
national authorities by the 15th of each month where these are to be reviewed and follow up action
taken. The national program should compile the monthly reports and share it with WHO. This
should be done for the previous year in the first two weeks of January. As the surveillance system
improves, the reporting to WHO should be done on a quarterly basis to facilitate early follow up on
the report. The countries should also work out arrangements for regular exchange of information
related to the districts that are on the international borders. This is proposed for synchronization of
elimination activities for effective cross border collaboration. Since Kala-azar is proposed to be
eliminated, an effort should be made for an intercountry review once in a year. External review of
61
the program including an in depth review should be planned once every two years. The suggested
frequency for review is summarized in the table.
4.2.5 Review and feedback of Kala-azar
The following steps need to be taken to review and provide feedback of Kala-azar:
Table 10 Review and feedback of Kala-azar
Level Staff involved Frequency
UHC Level I All level I staff, partner
NGO and private sector
Once in a month
District Level II All level II and concerned
level III staff, partner NGO
and private sector
Once a month
National program All district focal points,
sentinel surveillance sites
and specialized units
Once in 6 months (to be
organized once in 3 months
once the system of 6
monthly feedback begins to
work)
Inter country review National Focal points Once in an year
External review State and national focal
points, WHO and other
partners
Once in two years
4.2.6 Reporting of treatment
Treatment cards and registers are recommended for reporting of treatment. The basic information
comprises of the following;
• Information on the place, age, sex, marital status and pregnancy and its outcome
• Drug used for treatment of Kala-azar
• Number of days of treatment provided
• Treatment complete/incomplete
• Side effects of drugs
• Treatment provider (public, private, NGO)
62
• Number of patients where the treatment failed for each drug used
It is recommended that reporting should be done through line listing process to supplement the
existing reporting system. If line listing is found difficult to organize widely then to begin with the
line listing should be done in sentinel sites. The sentinel sites in each district should be selected in
the public and private sector at each level. These sentinel sites can be increased as the resource and
capacity increases.
4.2.7 Reporting of hospitalized cases
Separate reports are needed for indoor patients of Kala-azar. This should include the total number of
admissions, the total number of patients admitted for Kala-azar, the total number of deaths and the
total number of deaths due to Kala-azar. The report should be categorized according to age (under
five, 5-14 and 15 and above) and sex. Information on pregnant women should be included
separately in the monthly report. The outcome should be summarized as (a) cured (b) worsened (c)
died. To indicate the number of patients who worsened and were referred. The report should
indicate the number of patients who used the referral services. The monthly report should indicate
the number of patients who completed the treatment and the number of patients who are being
treated but have not completed treatment. It is also necessary to indicate the number of patients who
were started on treatment but have dropped out.
Criteria for cure
• Return of normal appetite
• Remission of fever
• Regression of spleen size
• Improvement in anaemia and a rise in hemoglobin
• The full course of treatment has been taken
• Increase in body weight
63
4.3 Surveillance of Kala-azar and PKDL
4.3.1 Passive surveillance
This is the mainstay of the program in the beginning. This means timely, regular and accurate
reporting of cases who seek diagnosis and treatment of Kala-azar and PKDL from any facility.
Passive surveillance should be done on a format approved by the National Kala-azar Surveillance
Centre. Patient card should be the starting point for passive surveillance. The following information
should be extracted from the records at each level:
• Number of patients of Kala-azar based on ‘rK-39’positivity
• Number of patients diagnosed by parasitological diagnosis
• Number of patients who are recruited for treatment of KA or PKDL
• Number of patients who are currently on treatment categorized according to the treatment
provided
• Number of patients who have completed the treatment
• Number of patients who has dropped out before completing the treatment
• Number of patients who did not respond to treatment categorized according to the treatment
provided
• Number of patients who were admitted to the hospital
• Number of patients who died in the hospital
• Number of patients who died at home
• Number of patients who developed major side effects of medicine
To begin with all the above information should be sent according to age and sex (below 5 years, 5-9
years, 10-14 years and 15 or more than 15 years) by the sentinel sites. The information on pregnant
women especially women in first trimester of pregnancy should be included separately. This should
be provided by the sentinel sites.
4.3.2 Sentinel surveillance
All health facilities in the Government, Private and NGO sectors are expected to participate in
passive surveillance. However, if there are inadequacies in the program and reliable or regular
information cannot be provided, the district health authorities should identify key institutions at
each level in the government, private and NGO sectors according to the table that has been
presented in chapter. To start with a certain number of health facilities/hospitals should be identified
in the district. They should maintain line listing and provide the information to the district health
authorities according to the format. These units are identified as sentinel surveillance units. The
number of sentinel sites can be enlarged based on the capacity in the district. The sentinel sites
should collect information through line listing in order to facilitate on line transmission. The basic
64
data set should be common for all the sentinel sites. Selected sites can take up additional
responsibilities which include the following:
• Monitoring therapeutic efficacy of medicines according to agreed protocols
• Quality assurance of diagnosis and treatment
• PCR testing in selected cases as a part of quality assurance
• On line transmission of data
• Development of capacity of staff.
4.3.3 Active surveillance
Active surveillance implies active search of cases of Kala-azar and PKDL. The active surveillance
is to be done through Kala-azar week or Kala-azar fortnight. Health workers and health volunteers
have to be oriented in the process of active case search through campaigns and house-to-house visit.
In India, during the Kala-azar fortnight health workers/volunteers visit the households to detect
cases of fever of more than 2 weeks and screen them with ‘rK39’. Those who are positive are
treated. The orientation of health workers and health volunteers builds up their capacity. The
campaign is successful when there are adequate back up facilities for the diagnosis and treatment of
cases of Kala-azar and PKDL. Active surveillance through case search should not be undertaken
until the program has established adequate services. Kala-azar fortnights are expensive and resource
intensive. The health worker may have to search about 300-400 households to get a case of Kala-
azar. Therefore it may take several days of effort to get a case of Kala-azar.
4.3.4 Options
Since house to house search is resource intensive and therefore not sustainable the national program
should consider various options and choose appropriate alternatives.
• Kala-azar is known to occur in clusters. When one case of Kala-azar is reported, a house to
house search or a camp can be organized. There are positive experiences from camps
organized to detect treat and follow up cases of Kala-azar in the community. An information
campaign should be organized before the search. Local terms should be used to get
information on cases. The diagnostic and treatment facilities for Kala-azar need to be
organized and the patients offered transport facilities (in case of referral) if required. If a
camp is organized then mopping of surrounding villages is recommended. A similar
65
approach is recommended based on mapping of cases of Kala-azar by the district health
authorities.
• Use snow balling technique in case search. Start from the household of a reported case and
cover the hamlet/village/a cluster of villages. This can be a house to house search or seeking
of information about knowledge of other cases in the neighbor hood from the affected
family.
• Contacting key persons during the visit to the village by the health worker to identify cases
with fever of more than 2 weeks duration.
• Organizing outreach activities in locations where people gather in large numbers e.g. large
village fairs.
• Seeking out information about Kala-azar cases while providing immunization and antenatal
services.
For the success of active surveillance, it is necessary to ensure that the diagnostic and treatment
facilities are provided. Arrangements are made for transport if the patient has to be referred,
organize timely follow up for feedback and provide services to patients who may not be suffering
from Kala-azar. It is also important to organize additional IRS campaigns to help in the reduction of
transmission.
4.3. 5 Surveillance of PKDL
The surveillance of PKDL is as important as surveillance of Kala-azar since cases of PKDL serve as
a reservoir for disease transmission during the inter epidemic period. The program should do
passive and active surveillance of PKDL. The reporting of cases should be an integral part of the
reporting. Special efforts are needed for surveillance of PKDL for the following reasons:
• Patients with PKDL have only skin manifestations and therefore often consult skin
specialists.
• PKDL can be confused with pauci or multi bacillary leprosy. The skin lesions may also
mimic other skin conditions
• The patients with PKDL do not have any other manifestations. Since the patients do not
have any discomfort they do not seek treatment readily
• The treatment of PKDL is prolonged and the medicines used have side effects. The patient
has little motivation to complete the treatment
66
• Young patients with PKDL are stigmatized because they are worried that there may be
problems in marriage prospects
The surveillance of PKDL requires demystification and innovations. The program may consider
incentivising for the reporting of PKDL and efforts are needed to make it stronger. The search for
cases of PKDL should be undertaken in a campaign mode.
67
Learning Unit 5:
INTEGRATED VECTOR MANAGEMENT
Objectives: at the end of session the participants will be able to
• describe the vector behaviour and bionomics
• describe the components of integrated vector control management (IVM)
• describe implementation of indoor residual spray (IRS)
• enumerate surveillance, monitoring and evaluation of vector control
measures
• take measures on personal protection
• learn about micro environmental management
• achieve community participation
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5.1 Vector Behaviour and bionomics
Phlebotomus argentipes is a small, dark grey, hairy insect about 2.5 mm from the tip of the mouth
till the last abdominal segment. P argentipes is probably the only species amongst about 50
phlebotomine species that transmits kala azar to humans in the Indian subcontinent (Bangladesh,
India and Nepal). It thrives best in alluvial soil, in areas with relatively even temperature, high
humidity and abundance of cattle population. Eggs and larvae of the sandfly can withstand
immersion in water for a period of 5 days and the larvae of the fourth stage can withstand the
immersion for a period of 14 days. Thus they can survive even flooding. Breeding places are found
within a radius of about 20-50 meters from a dwelling in dark, humid soil protected from the
sunlight. In the cattle sheds, the favorite breeding places are floor periphery with moister and
organic debries. Troughs found in and around cattle sheds are other important breeding sites of
sandflies. Immature stages are also often found in loose soil crackes and crevices in and around
dwelling houses and cattle sheds. Mud houses are the main site but also found in old brick built
houses. In the households, the adult sandfly thrives in cracks and crevices both indoor and out
doors. Only the females suck blood and they prefer cattle to human blood. Transmission can occur
after a heavy build up of the sandfly population because the sandfly shifts from cattle to humans
only after it has exhausted the option of blood meal from the cattle.
Adult sandflies are active after dark while during the day they escape into their resting shelters.
Since the habitat of the sandflies is mainly indoor, it has implications on the effectiveness of control
measures. The sand flies are poor fliers and they can hop only short distances. It cannot fly above a
height of 6 feet. P. argentipes is a wet zone species. The highest risk of disease transmission in
Bangladesh is therefore observed from the month of April to September, the months when the
humidity is high (75-85%), Susceptability test have shown that the sand fly is susceptible to
insecticides so far tested (e.g. Malathion, Permethrin, Deltamethrin and Fenitrothion).
The vector behaviour and bionomics that make interruption of transmission achievable in
Bangladesh and adjoining countries include the following factors:
• There is probably only one species of sandfly, Phlebotomus argentipes that transmit kala-
azar in Bangladesh.
• The vector is so far sensitive to insecticides, tested as mentioned above.
• The insecticide spraying can be done with economy since the spraying is required up to a
height of about 2 meters only and the operations may be confined to only the households,
69
cattle sheds and some outdoor sites. This entails a saving of about half the costs when
compared to IRS for malaria.
• There is a historical evidence of interruption of transmission as a collateral benefit of
malaria eradication programme when kala azar was virtually eliminated from the
subcontinent as a result of insecticide spraying.
• The operation of IRS is to be limited to geographical area affecting 45 districts in
Bangladesh. Since cases are found in rural areas, IRS should be carried out in villages.
• Cross border collaboration in IRS operations can interrupt the transmission of the disease in
the border areas. So simultaneous IRS operation can be organized with the neighboring
countries (e.g India).
5.2 Integrated vector management
Integrated vector Management (IVM) is recommended as a part of public health policy since this
strategy uses the following.
• decision making procedures based on the knowledge of vector biology and disease
transmission;
• targeting of multiple vector control;
• planning and application of targeted interventions often in combination and synergistically;
• rational use of insecticides;
• use of cost-effective interventions that are suitable for the health system;
• multi-sectoral partnerships
• involvement of communities, including planning and decision making at the lowest possible
administrative levels;
• measurable impact on disease transmission risks and
• use of effective public health regulation and legislation.
70
5.3.1 Key steps to be undertaken in planning
1. Stratify areas according to disease burden and epidemiology of Kala-azar:
Area of operations and estimated population to be served are as follows-
Out of total 64 districts and 460 rural upazillas in the country with 143 million populations the kala-
azar elimination programme in Bangladesh is targeted in 130 upazillas in 45 districts with an
estimated population of 51.6 million.
Table 12 shows the overview of the areas as per endemicity.
Endemicity No of upazilla Major interventions Comments
High endemic
More than 2.5 cases
per10,000
population
25 Treatment of cases
IVM(IRS,ITN,EVM)
IEC
Surveillance
Average Nos of HHs in each
Upazilla is 60000 and target
HHs for spraying will be 48,000
(8o% of the total HHs). Thus a
total of 1,200,000 HHs need to
be sprayed.
Moderate endemic
1.1 to 2.49 cases per
10,000 population
30 Do The total estimated HHs for
spraying HHs will be 40% of
total HHs (24,000) thus a total
of 720,000 need to be sprayed.
Low endemic
0.44 to 1.09 cases per
10,000 population
75 DO These areas to be under proper
surveillance and IEC of the
people. Only focal spraying
should be done here. A total of
10% HHs may need to be
sprayed (A total of 450,000
HHs.)
Total 130 Total HHs to be sprayed per
round 2,370,000
5.3.2. Determine the objective of vector control based on eco epidemiology of Kala-azar.
5.3.3. For the vector, determine the adult resting sites and behavior and breeding habitats that are
relevant to IRS; biting habits that are relevant to ITNs and other personal protection methods;
insecticide susceptibility/ resistance status to select the appropriate insecticide.
5.3.4. Determine the methods of vector control that are most suitable.
• Method to reduce the longevity and abundance of vectors
• Method for quick reduction of vector population
• Methods to reduce human vector contact
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• Micro environmental management to reduce the vector breeding
• Legislation to ensure application of preventive measures and for safeguards
• Personal hygiene
• Feasibility, cost effectiveness and community acceptance.
5.4 Vector control options
Prevention of Kala-azar and transmission reduction are the major strategies in the elimination of the
disease. The standards and standard operating procedures for prevention of kala azar require
application of the right mix of interventions based on vector behaviour and vector bionomics.
Integrated vector management (IVM) for elimination of kala azar comprises of the following:
• Indoor Residual Spray (IRS),
• Personal protection to prevent human vector contact. This includes the use of insecticide
treated nets (ITNs),
• Microenvironment management (households and living conditions)
5.5 Indoor residual spray (IRS)
At present IRS is the mainstay of the programme. To maximize the impact, IRS and case search
should be synchronized. The objective of IRS is to ensure safe and correct application (uniform and
complete) of a residual insecticide to indoor surfaces of houses, animal shelters and other important
outdoor resting sites , e.g. cattle troughs, out door base (plinth) of the houses etc. This will help in
achieving a marked reduction in the populations of vector sand fly and consequently a sharp
reduction of Kala-Azar transmission in the target areas.
5.5.1 Planning and operations for Indoor Residual Spray Operation
The success of IRS operations depends on planning and implementation of the plan. The plans for
IRS operations should be developed before the end of the year so that there is no last minute rush
during the implementation. The planning should include the following steps.
5.5.2 Selection of areas for IRS
The vectors are shifting to new areas. Therefore selection of the area to be sprayed should be
adjusted accordingly. The programme should make this decision based on its capacity for achieving
complete, regular, timely and uniform coverage. Number of houses to be sprayed in the villages
should be selected according to Upazila in Bangladesh. The areas to be sprayed can be identified
best by mapping of the areas through geographical reconnaissance (GR) in Bangladesh. House
numbering was initiated by MEP in early 60s. Time to time, this has been upgraded for different
72
activities. If same house number is missing, this should be done through existing system under
health services before IRS starts. This could be done also by geographical informational system
(GIS). If GIS is not available, the following criteria are recommended for selection of localities and
households for IRS.
1. All villages that reported a case of kala azar during the last five years
2. All villages that report a case of kala azar during the current year
3. Villages that have not reported kala azar but on search have cases
4. The entire village will be covered if selected for IRS.
5. If any positive case is found in border areas of the target area villages, house holds within 50
meter around (if any) of the neighboring village should also be put under IRS.
5.5.3 Timing of the IRS
Two complete rounds of IRS should be considered for three year. The first round should be in
March-April and the second round in the month of August-September.
The suggested timing of insecticide spraying has been calculated based on the previous
entomological findings in Bangladesh.
5.5.3.1 Monitoring and Evaluation
To evaluate efficacy of IRS, entomological investigation should be carried out twice a year
preferably in May-June and October. Investigations should include collection of sandflies by light
trap and bioassay of the treated surfaces. Susceptibility of sandflies to deltamethrin should be
checked yearly, preferably in March-April.
5.5.4. Choice of insecticide and the estimation of quantities needed
As DDT has been banned for public health spray in Bangladesh, Deltamethrin has been selected for
IRS in respect to Kala-azar vector. This has been done so as it has been found highly effective
against the sandfly. It has got least mammalian toxicity.
The selected insecticide has got the following characteristics:
- Long lasting effect on sprayed surfaces (3-6 months).
- Highly toxic to the target insect.
- Least repellency to the insect.
- Safe to humans and domestic animals
- Acceptable to the community
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- Stable during storage and transportation
- Good suspensibility so that it mixes well with water and does not clog equipments
- Cost effective
The re recommended dose of deltamethrin is 0.02-0.025 gm/m². Its effectiveness remains 3-6 months.
Insecticides suitable for IRS for sand fly control (WHO recommended)
Table 13 Insecticide used for indoor residual spraying
Insecticides
Recommended
dosage
(gm/m2)
Effectiveness
(Months)
Insecticidal
Action
Safety
Organochlorine
DDT
2 g/m2
6
Contact
Moderate
Synthetic pyrethroids
Alphacypermethrin
Cyfluthrin
Cypermethrin
Deltamethrin
Lambdacyhaluthrin
Permethrin
0.03
0.025
0.5
0.05
0.025-0.05
0.05
2-3
3-5
4 or more
3-6
2-3
2-3
Contact
Contact
Contact
Contact
Contact
Contact
Bangladesh has selected deltamethrin, which should be used as100gm sachet for 10 liters of water.
Approximately one sachet will serve one household (rooms, cattle shed and other sites).
5.5.5 Equipment needs for IRS
The equipment needs are determined on the basis of the national policy. Hand operated compression
pumps, preferably Hudson Xpert sprayer (10 liter capacity) should be considered since the use of
this equipment requires one operator and spraying of better quality can be achieved.
Each spray squad would need the following equipment:
• Hand compression pumps (5)
• Spray nozzle tips for spray pumps (2) extra.
• Plastic Bucket 10 liters (2)
• Mug (2)
• Straining cloth (1 meter)
• Pump washers (2)
• Register for records (1), forms.
• Writing material to identify households covered by IRS
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• Tools for minor repairs of spray machines.
• Personal protection equipment for each member of the squad including a pair of gloves.
Instructions for spray man have been shown in annex No. 12
5.5.6 Manpower requirements
Through appropriate planning and deployment of staff, the spraying should be completed within 30
days. Usually labor on daily wage will be employed to undertake the job. The spray squads should
be supervised adequately to ensure the quality (correct dose, uniformity and completeness of
application) of IRS operation. Therefore, the training and supervision components should be strong.
The supervisor of the spray teams (number to be decided by the programme) should be a regular
government staff member. The average squad for spraying should comprise of 5 field workers and
one squad leader who should be Health Assistant (H.A). One of the field workers will help in
collection of water, preparation of spray & household preparation. This activity should be rotated
among the field workers. The number of houses to be sprayed is determined by the terrain in which
the team is operating. In one day, 10-12 houses can be sprayed by one spray man. District planning
is needed to identify the number of houses to be sprayed. The number of houses to be covered in a
district would vary according to the criteria already identified earlier. The population to be covered
should be divided by 5 since each household has an average of about 5 members. Calculate the
number of spray team that would be required in each district based on the number of houses to be
sprayed. In Bangladesh, many districts have got 1.5-5 million populations.
Assistant Health Inspector (A.H.I) will supervise 4-5 spray squads in a union. Health Inspector
(H.I), Sanitary Inspector (S.I) and family planning personnel of Upazila Health Complex and other
supervisory personnel of Upazila, Districts and Divisions should actively supervise spraying
operation. Supervisors should be provided with adequate support including logistics.
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5.5.7 Training of spraying squads and supervisors
The training of IRS team comprises of training of the health workers who are responsible for
supervising the spray operations, and training of the spray teams Health Inspectors or Health
superintendents should be the focal point for Kala-azar spraying and will be responsible for
organizing the training under the guidance of UH&FPO and CS. The training schedule comprises of
the following components:
• Importance of uniform and complete spraying
• Obtaining cooperation from the community
• Safe storage of the insecticide
• Preparation of insecticide suspension
• Correct use of the equipment
• Maintenance of the equipment
• Safety precautions and personal protection measures to be observed during the spraying
operations
• Safe disposal of insecticide waste.
The training should be of at least 3 days duration and include both theoretical and practical training
on the correct use of spray equipment and the observance of all the steps needed from the
preparation of the suspension to safe disposal of left over insecticide suspension. The training of the
supervisors should include community involvement for ensuring community acceptance and
participation, which in turn is expected to achieve the completeness of coverage in all the targeted
dwellings, cattle sheds and other breeding resting places. The training of the supervisors should also
include supportive supervision, which includes the use of a standard checklist and problem solving.
In one training maximum 25- 30 persons should be included.
The norms for training of the supervisors and spray team members should be developed based on
the standards and standard operating procedures. The training of the spray team members should
include solving of problems. The person responsible for solving the day to day problems of spray
men is the spray squad supervisor.
Each district proposed to be covered by IRS should develop a training plan. The training should be
completed one week before the first spraying operations. Avoid a long interval between the spray
operations and the training. It should be an integral part of the district work plan for elimination of
76
Kala-azar. Each district should prepare a report on training of the supervisors and the spraying
teams.
Table 14 Report on training for IRS- District
Report on training for IRS- District
Total
number
Batch(No.) Dates Venue
1.Supervisors
2. Spray team members
(Asst. Health Inspector,
Health Inspector, Health
Superintendent, Sanitary
Inspector, and District
Entomologist.)
5.5.8 Transportation, storage and safe handling of the insecticides & equipments
The containers in which the insecticide is transported should be well sealed and properly labeled.
The insecticide transport should not be done along with transportation of the food items. In
consultation with the community, the insecticides and other equipments should be stored in a safe
place where the chances of contact with humans are minimal.
Make sure that the insecticide is properly labeled with the name of the insecticide, the name of the
manufacturer, date of manufacture, the date of expiry and the danger sign that it is a poison. There
should be written guidelines with each sachets what to do in case there is exposure to the
insecticide.
The insecticide should be stored in a well-ventilated room, not exposed directly to sunlight and
away from the walls. The place where the insecticide is stored should be away from the reach of
children and animals. It is important to be sure that no food items are stored in the vicinity of the
place where the insecticide is stored.
The storage should be carefully done. The stocks that arrive first are to be used first and make sure
that the expiry date has not been exceeded prior to its use. Stock registers should be carefully
maintained to keep a track of the use. No unauthorized person should have access to the
insecticides.
77
The storeroom where the insecticide is stored should be kept locked and the danger sign should be
displayed to indicate that this is a location where hazardous material has been stored.
Eating, drinking and smoking are not permitted in the place where the insecticide is stored. This is
not allowed during the spray operations also.
5.5.9 Spray programme
The district plan should include a plan for IRS developed on the basis of criteria identified above.
The plan should include identification of dates when the selected villages are proposed to be
sprayed. Each supervisor should then develop a plan for each spray team. This plan should be used
to calculate the requirement of the insecticide, which should be supplied and safely stored at least
one week before the spray. A prototype framework is summarized in the table.
Table 15 Upazila Health complex (UHC) spraying programme by one spraying squad
UHC Sub centers Village (for
sub center 1)
Date of spray Name of Spray
team members
Name 1 Name 1 Village 1
Name 2 Village 2
Name 3 Village 3
Name 4 Village 4
Name 5 Village 5
Name 6
5.5.10 Spray operations
Spray operations comprises of estimation of needs for each squad, correct use of spraying
technique, full coverage of all the targeted households.
All indoor surfaces of dwelling houses, cattle sheds, chicken houses, pigeon holes & and other
possible sandfly resting places, around houses, including out door plinth of houses should also be
sprayed up to a height of 6 feet. Out door surfaces of tin houses need not to be sprayed. Ten liter of
water in a 10 liter capacity sprayer should be used for spraying. Fine mesh strainer should be used
78
before pouring water. Pour one sachet of powder (100 gm) into the tank of sprayer. This quantity
should be sufficient for one house hold.
Care should be taken for proper maintenance of the spraying equipment and preparing daily reports
with stock checking. A pyramid sign without the bottom line should be marked with the chalk by
squad leader (Health Assistant -HA). On the door of the household to be sprayed. On completion of
the spraying the squad leader will check the sprayed surfaces and if found satisfactory, then he will
complete the pyramid by putting the underline.
Deltamethrin for spraying will be provided in sachets by the national programme. Each squad
should be provided with 50 sachets (100gm each) & the team supervisor (A.H.I, H.I) should
maintain an account of the same.
Based on the plan for IRS, a village wise detail programme should be developed by the supervisors
with indication of the number of households to be covered in each village. Four copies of the spray
schedule should be prepared by the supervisory personal and distributed as follows, 1) one copy to
squad leader, 2) one copy to supervisor, 3) one copy to Upazila Health Complex (UHC) and 4) one
copy to Civil Surgeon office at district head quarter. This would facilitate the supervision of the
operations.
5.5.11 Spraying technique
It is extremely important that the technique of preparation of the suspension and of spraying meets
the recommended procedures. This is summarized in the annexure-13.
5.5.12 Post spray activities
The post spray activities include stock taking of the work completed, preparing a report, disposal of
the material which could not be used, maintenance of the equipment, estimating the requirements
for the next day and planning spraying in the villages that have not been covered.
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Disposal of the insecticides and the containers/sacs in which the insecticide is stored
• The unused insecticides or the washings should be disposed off safely to
ensure that it does not mix with water or food.
• Prepare only the required quantity of insecticide suspension, which is likely to
be consumed in one day. Do not carry over any unused insecticide
suspension the next day.
• Never put any left over insecticide into a river, pond, well or source of
drinking water.
• Any spilled insecticide in solid or liquid form, the washings from the
spraying, should all be emptied into a pit which is dug away from the source
of drinking water and covered with mud.
• Do not use the empty sachets in which the insecticide was stored for any other
purpose. These must be buried safely away from the drinking water source.
5.5.13 Daily Summary, reporting of information
At the end of each day, the spray squads should prepare the summary of day’s work. This includes
information on the households targeted, households sprayed, insecticide consumed, insecticide left,
and the problems encountered in the work. A daily summary of spray operations should be
maintained, showing the areas covered, percentage room coverage and insecticide consumption in the
tables as shown below:
Table 16 Daily summary report of information of one squad
Spray Operations at Upzilla (Name) ________________________ Date _____________
Village/Union Targeted Sprayed
Houses Rooms Houses Rooms Locked/
Refused
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Table 17 Daily consumption record of insecticide
Spray Operations at Upazila (Name)_______________________ Date_____________
__________________________________________________________________
Insecticide
sachet issued
Balance
insecticide
available from
previous day
Total No. of sachet
used
No. of sachets
left
The daily report should be sent to the supervisor by all the spray squads for review and feedback by
the supervisor in order to take corrective actions if required. The supervisors in turn should send the
consolidated report to the focal point in the district once every week.
5.5.14 Informing and involving the community
The supervisors should inform the community leaders and key persons in the villages about the
plans for the spraying at least a week before the spraying is done. The spray team members should
remind them at least one day before the operation. During the first visit discuss the following issues
with the community leaders and key persons in the community.
• Distribution of a simple leaflet explaining the purpose of the spraying and including the
common do’s and don’ts (prototype included in the annexure) developed in local language.
Simple illustrations should be included to facilitate easy understanding of the people. This
should be a part of BCC. The leaflet should be left with several key persons in the village for
distribution and briefing amongst the sections/segments they represent or influence. Tell the
key persons to share the contents of the leaflet to others in the community.
• What is proposed to be done and why. Explain that this is the most effective way of
eliminating a dreaded disease kala azar. Their cooperation will be a key to success of the
efforts.
• Inform the proposed date for spraying the village
• Discuss what specific role the community leaders and key persons can play to ensure that
the spraying is complete and thorough. This would require that no household is missed and
the spraying done must be complete.
• Explain that if all surfaces are not sprayed the sandfly would fly to the uncovered areas and
the desired effect of spraying will not be obtained.
• The insecticide is harmful for the food items. Foods must not be exposed to the insecticide.
81
• The households must not do any mud plastering of the walls and the sprayed surfaces for at
least 6 months after the spraying.
• One day prior to the spraying, announcement through mosque microphone might be a useful
way of informing and reminding the villagers. Other suitable options may be taken up in
place of announcement through mosque microphone if that is not available.
5.5.15 Supervision of IRS
Supervision is an essential and integral part of IRS to ensure its efficacy and safety. This should be
thorough to produce an impact and ensure that there are no ill effects. To be effective, supervision
should be carried out at all levels. There should be a written plan for supervision and supervisory
checklists are to be developed and used. Supervision will be effective if problems are identified and
they are solved by the supervisors as soon as they are detected. Any unsolved problems should be
referred to district authorities for resolution. All supervisory reports should be sent to the district to
facilitate follow up action. The supervisory reports should be kept safely in the district and referred
to whenever needed.
• Availability of plan with the spray squad. Review of the plan to ensure that the plan is being
followed.
• Ensure that all members of the spray squad are present and are doing the job.
• Checking that the spraying is being done correctly according to the norms prescribed in the
work manual of the spray squad.
• Examination of the spray equipment to ensure that it is in working condition and is being
properly maintained as per the guidelines provided.
• Going with the squad to the households where there is refusal or reluctance for spraying
• Checking the records of the spray squads
• Discussions of plans for mopping up to cover the households where there was refusal or the
houses were locked.
• Assessing the consumption of insecticides and making arrangements for additional supplies
if required.
• Review of time schedule for the following week
The supervisor should also undertake the following activities while on a supervision mission:
• Visit randomly selected households and ask whether the house was sprayed or not.
• If the house was sprayed, then check for deposits as evidence for spray.
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• Check whether the deposits are uniform or not. Uniform deposits indicate that the spraying
was satisfactory
• Check to see if any portions of the dwelling or the cattle shed were skipped.
• Check whether the walls have been plastered with mud. If the walls have been plastered then
determine when this was done to determine the time interval between the IRS and the
plastering.
• Visit the households that were not covered and find out the reasons for non-coverage. Try to
convince them to get their houses sprayed as a part of special mop up drive.
• Prepare a written report along with recommendations and share with the spray squads to
ensure that the mistakes are corrected as soon as possible.
5.6 Vector surveillance
Vector surveillance is a critical component of the programme since it helps to plan IRS operations
based on evidence. It is also necessary part of the elimination strategy because it is useful in
determining the impact of IRS.
There are no easy methods for estimating the size of sandfly population reliably.
Standardized active catch- skilled insect collectors search the habitations of the sand flies and catch
all the resting sand flies. This must be done on similar days of the week for a comparable duration.
This method is useful for endophilic sandflies and has been extensively used in the sub-continent.
The results are expressed as the number of sandflies caught per person per hour.
Trap collection
Sand flies should be collected by light traps (e.g. CDC light trap) placing them inside the houses.
Such traps should be set at sunset and be removed at sunrise. Result should be expressed as per light
trap per night.
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Table 18 The methods recommended by WHO for sand fly collection are summarized in the
table
Vector control method Entomological parameter Recommended
monitoring
Indoor Residual spray Day time indoor resting Regular
Light trap collection Regular
Bio -assay Monthly, for 6
months.
Insecticide susceptibility testing Yearly
5.7 Monitoring of Insecticides Resistance:
Vector resistance to insecticides results from repeated insecticide use and selection pressure thus
generated. A rotation policy can help delay the occurrence of insecticide resistance. However, it may
be difficult to implement. Ideally, the available insecticides should be used as part of an overall
strategy to maximize the useful life of each product. However, the susceptibility of the Kala-azar
vector needs to be constantly monitored in view of the resistance to synthetic pyrethroid,
deltamethrin, in related species of Phlebotomus and Sergentomyia. Such tests should be carried out
once a year in several places.
5.8 Personal protection to prevent human vector contact:
As a component of IVM, personal protection from sandfly bites is an important component. People of
endemic areas should be educated about how they can protect themselves from sandfly bites. In this
respect, the feeding and resting habits of sandfly and the cultural practices and sleeping habits of the
people are important determinants of the efficacy of personal protection measures. This measure is
most effective because the vector sandfly is mainly endophilic and endophagic. As such, member of
the community should be educated first but before that their knowledge, attitude and practices (KAP)
about Kala-azar transmission and control are to be assessed. The areas where people can take role in
avoiding vector contacts are as follows:
• Use of bed nets, preferably impregnated / treated bed nets (ITNs)
• Use repellants: coil, aerosol, spray, vap-mat, body cream and oil, etc.
• While working outdoors, use long sleeve dresses, socks, head gear, etc.
• Retire early to bed at night
• Keep animals near dwellings
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• Keep house clean and airy
• Parents should be advised to dress their children with long-sleeve cloths during evening to
bed time.
The above mentioned information should be given to the public through different methods of health
education. Meeting with public with such information will be the best method of health education.
For such efforts, local leaders, imams, school teachers, NGOs, etc. should be involved. They should
be trained first and ultimately they will act as trainer and give these massages to the public. Hand
bills and leaflets will be distributed to educate and motivate the people. Use of ITNs is reducing man-
vector contact is gaining momentum in vector control. As such, it is dealt separately.
Insecticide treated nets (ITNs)
Insecticide treated nets are used as barriers or repellents to reduce human-sandfly contact. Several
studies at home and abroad have shown that ITNs can help in lowering vector (sandfly) density and
repelled others and thus ultimately help in reducing kala-azar cases.
It can be done in three ways:
1) By impregnating the bed nets with suitable insecticide. Now Deltamethrin (KO tab 123) is
available in tablet form. One tablet can be used for one bed net which will remain effective for 5
years. People will bring their bed nets at certain treatment place and health authority/NGOs will
impregnate them.
2) Long lasting insecticide treated nets (LLITN) have been introduced for human use to restrict man-
vector contact. Govt. may explore the possibility of distributing LLITN in kala-azar affected areas
as is being done in malaria affected areas through Global Funding for AIDS/ Tuberculosis / Malaria.
3) LLITN should be made available commercially in the market so that people can buy them and
use them like other mosquito nets.
Such nets act as bite inhibitor or repellant or as knock down agent or even kill the vector.
People in Bangladesh are habituated in using mosquito nets. As such, if they are educated regarding
use of ITNs, then they will either impregnate their nets or buy the long lasting nets.
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5.9 Micro-environmental management (Household living condition)
The term environmental management refers to the modification and/or manipulation of
environmental factors or their interaction with man with a view to preventing or minimizing vector
propagation and reducing man-vector contact. It is aimed at preventing, eliminating or reducing the
habitats of vectors without causing unduly adverse effect on the quality of human environment. In
case of sandfly, the control environmental management methods of control are generally directed at
the elimination of breeding sites in and around houses. Breeding habitats though difficult to locate,
should be searched and destroyed. Places around houses or cattle sheds should be kept clean and
plastered at regular intervals preferably monthly. Cattle shed, loose soil, rich with organic materials,
should be removed daily. Heaps of rubbish and other probable breeding sites should be eliminated.
People in villages can do the following activities to make the environment unsuitable for vector
breeding and adult resting.
1. Community should be advised to plaster walls and plinths of dwellings and cattle sheds to
close cracks and crevices at least at a monthly interval.
2. Mouth of containers used for storing food grain should be covered.
3. If possible the side walls of troughs should be plastered.
4. Cattle shed floors should be cleaned at regular interval.
5. Plant extracts, such as neem, should be applied to cracks and crevices to prevent breeding.
6. Rooms should be kept clean and airy. Various household materials should be kept in orderly
fashion so that sand flies do not get resting sites.
5.10 Research
Though it is a time limited kala-azar elimination programme, a research component should be kept to
improve / rectify the elimination programme as and when necessary. Problem- solving researches that
have direct relevance to vector control is an essential component of any operational programme. Such
research aims at increasing the operational impact of elimination / control interventions. The
objectives are to develop or improve field techniques and asses the relevance of currently used
indicators and to develop innovative vector control techniques and approaches for the control of
Kala-azar.
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Some researchers both operational and applied are mentioned here for consideration of conducting
with this elimination programme.
• Examine the efficacy, cost effectiveness, acceptability and use of available control tools in
areas with different ecological and epidemiological characteristics.
• Design and evaluate integrated / selective vector control strategies based on sound field
research and develop optional strategies for cost-effective implementation.
• Determine the role of other sandflies other than P. argentipes in disease transmission in
Bangladesh.
• Breeding habitats of sandfly.
• Introduction of GIS to demarcate areas of disease occurrence
• Develop or improve vector control methods that are locally affordable and included in
environmental management activities of the elimination programme.
Such researches could be under taken through collaborative works between control programme
personnel and members of research institutes, e.g. IEDCR, NIPSOM, ICDDRB and Universities etc.
This would permit sharing of national resources (both human and logistics) and information and the
development of research proposals relevant to local needs that might be considered for funding. It
would be both productive and cost effective.
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Learning Unit-6
BEHAVIOUR CHANGE COMMUNICATION
Objective:
-at the end of the session the participant will be able to
• understand about the concept of Kala-azar
• Able to organize advocacy, publicity & disseminate kala azar messages
• motivate the people about kala azar
• Suspect kala azar fever & refer the cases to UHC & District Hospital
• keep records properly
• follow up the cases
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6.1 Background
The national programmes for Kala-azar elimination are currently focused on increasing the
awareness about the problem and possible solutions. The strategy used comprises of IEC. In
addition, campaigns are organized in India as Kala-azar fortnights and as Kala-azar week in Nepal.
In these campaigns, the health care workers and volunteers visit house to house for case search.
Suspected cases are tested by ‘rK-39’ and those who are positive are given the treatment. These
efforts are supported by awareness generation. An in depth review on Kala-azar in India was
carried out in 2006 and phase I studies in the 3 countries supported by TDR, were completed. These
studies were reviewed in Varanasi in April 2007. The evaluation and reviews have shown that
people are aware of Kala-azar and its consequences. The disease is frequently attributed to
mosquito/sandfly. This knowledge and awareness is not enough since people do not take
appropriate action.
The environment is not favourable for people to change their behaviour. Kala-azar often occurs
amongst the poorest of the poor, those who are illiterate and powerless. At the same time the
treatment services are no not easily accessible to them. High treatment costs, and loss of wages
during treatment are other deterrents. Consequently IEC efforts are having little impact on
behaviour.
6.2 The need for behaviour change
When the behaviour does not change the programme response is to do more of what has been done
i.e. print and distribute more pamphlets, posters, flyers, and start TV features and radio
programmes. This may increase the knowledge and awareness but does not bring about a change in
behaviour. Even when people are aware of the problem they are reluctant to do anything. Knowing
what to do is different from actually doing it.
For behaviour to change, it is important to make sure that as a first step people are informed about
the problem and solutions. This should be followed by convincing the people about actions to be
taken. An enabling environment is needed to encourage the people to take action. This should be
followed by helping the people to take action and supporting them during this process. Finally it is
necessary that the action is sustained to have an impact.
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6.3 Behaviour change for impact
Strategic communication for behaviour impact is needed for behaviour change to occur. To create
an impact it should be an integral part of social mobilization. A BCC strategy is needed for the
following reasons:
• To influence planners, policy makers, other stakeholders for intersectoral involvement
• To mobilize additional resources and optimally use existing resources
• To use ‘influencers’ in the community for the empowerment of the community
• To empower and motivate community with information for appropriate behaviour
• To get maximum output vis-à-vis the inputs
• To get behaviour impact
• To monitor and measure the impact
The behaviour change communication strategy should define clearly, (a) why behaviour change
communication is required (b) what are the specific actions that comprise BCC (c) who are the care
takers and care recipients (d) when is BCC proposed and (e) where is BCC proposed to be
undertaken.
The first step is to create an enabling environment. This means allocation of adequate resources for
BCC, improvement in services delivered and increasing the access to services
6.4 Advocacy and social mobilization for behaviour change
Advocacy is a strategy to develop an enabling environment to influence political leaders, elected
representatives, planners, policy makers, corporate sector, media, organized sectors, professional
bodies, academia, and the media. The objective is to enlist their commitment on a sustainable basis
to become ADVOCATES for the programme.
Advocacy is needed to create policies or reform existing policies, and ensure that policies are
implemented. There are a variety of advocacy strategies, such as discussing problems with policy
makers, contacting political representatives, delivering messages through the media, writing letters
to the editor/articles, or strengthening the ability of local organizations to advocate, organizing
community meetings, distributing educational materials or other means to communicate one's
views. Advocacy should be initiated at different levels.
• Sustained and appropriate advertising, which is massive, repetitive, intense and persistent
using a blend of channels by partnering with media
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• At the community level, community mobilization, involving NGOs/CBOs (Self-Help
Groups), Local self-Government, informal service providers including traditional medicine
men and faith healers, schools, traditional media, song and dance, drama etc. is important.
• At the local level ‘Influencers’ can play an important role in advocacy for the programme.
These are the people who have suffered from Kala-azar and recovered as a result of
treatment. Influencers can also be local influential people who are supportive of the
programme. They need to be articulate and interested in participating in the behaviour
change effort. This strategy of personal selling through interpersonal communication is
known to contribute substantially to impact. It involves listening to the problems of the
people and identifying solutions for solving them.
• Point of service promotion at level I health care delivery system, other local facilities as well
as fairs/festivals to emphasize and coordinate the behaviour change communication with
effective delivery of the products and interventions.
• For successful implementation of social mobilization the following IEC materials to be
developed, displayed and distributed in the endemic areas:
o leaflet
o poster
o sticker
o calendar
o billboard
o wall writing
o TV spot/ drama serial
o radio talk show
o documentary
o campaign (Kala-azar week; preferably in winter)
o Utthan boithak
6.5 Key steps for Planning for behaviour change
6.5.1 Multidisciplinary planning team
Constitute a multi disciplinary planning team with clear terms of reference. These include the
following:
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• identify preliminary behaviour objectives;
• plan for formative research:
• review the findings of research;
• finalize the behaviour objectives for impact;
• design a strategy and develop a plan;
• assist in mobilization of resources required;
• guide implementation and review the experience to guide the programme.
It is important that in this group, contributions from social sciences are available in a sustained
manner. Marketing and advertising people should also be a part of this group.
6.5.2 Identify preliminary behaviour objectives
These are not final objectives but are to be addressed during formative research.
a) People suspected to be suffering from Kala-azar/PKDL utilize the services early in the
disease for diagnosis and treatment from trained health care providers
b) Cases of Kala-azar/PKDL complete treatment
c) Household members ensure that the spraying is complete
d) Personal protection measures are practiced to reduce human vector contact
Through participatory consultations with stakeholders, these objectives should be narrowed down to
2-3.
6.5.3 Undertake formative research
Undertake formative research to assess (a) the behavioral environment and (b) the policy and
programme environment in support of BCC. The context is to examine in details the preliminary
behaviour objectives and undertake field research to provide experience to help refine the behaviour
objectives with enunciation of behaviour impact. The formative research should lead to
identification of strengths and weaknesses as well as discuss opportunities and threats; forces for
and against adopting a certain behaviour; motivational barriers; community need/want/desire; cost
vs value of an expected behaviour; communication keys, etc.
Review and analyze the findings of formative research to identify the behaviour objectives,
prioritize them and finalize the objectives. Preferably do not choose more than two-three objectives.
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The objectives should be adequate to meet the needs of the programme. Further objectives can be
added based on experience. The objectives should be precise and quantitative and answer the
questions raised earlier.
6.5.4 Segment the target audience
It is necessary to segment the target audience to identify the key audience that share similar
characteristics and are most likely to respond to similar stimuli for bringing about a change. There
are certain segments more in need of the behaviour interventions than others. Since they are the
poorest of the poor there are not likely to be any political sensitivities if resources are committed.
Within this segment there are more willing groups and others who are not quite ready. The willing
groups should be targeted first. The segment chosen should be large enough and reachable. The size
of the target group should be manageable and the resources should be adequate to be able to reach
the segment. . On the basis of learning experiences of the Kala-azar elimination programme, a
comprehensive BCC strategy will be develop later on.
6.5.5 Develop a BCC strategy
Based on the objective (s) and the target audience, strategy and activities to achieve the objective
are to be articulated in the plan. The activities comprise of development of message, source,
channel, the receiver, effect, feedback and the setting. Communication comprises of a message
transmitted via a channel from a source to the receiver to produce an effect that provides
opportunity for a feedback in different settings. Message should be simple and clear. The source
(provider of the message) should be a credible person who is acceptable to the population group
addressed. Source can vary depending on the target audience. It is important to include the channels
that are most likely to create an impact. These include traditional media and other locally acceptable
channels. Community radio, video spots through mobile vans, miking, illustrative materials, etc
should also be considered. The channel mix is important. In this context the value of interpersonal
communication deserves the required emphasis. A blend is required comprising of the right mix of
advocacy, advertising, the use of mass or local media and interpersonal communication. The setting
in which communication is done is very important. Religious venues, fairs and festivals, health
centers, market places and schools are venues to be considered but the setting should be
comfortable. As a result of the efforts there must be an effect on the target audience. The feedback
determines the changes that are needed to fine-tune the programme. Develop the products and
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materials focusing only on the objective to be achieved. This should be pretested with intense
involvement of social and behavioral scientists. This process includes testing of the products
developed including behavioral trials on the segmented audience.
6.5.6 Develop monitoring and evaluation framework
Develop monitoring system and plans for implementing the system- this comprises of behaviour
monitoring and media monitoring plans. It is necessary to prepare a framework and develop
capacity including commitment of resources to monitor and evaluate the implementation of BCC.
The focus of monitoring and evaluation is on the outcome that is achievement of behaviour change
impact objectives. Developing monitoring tools & checklist for Kala-azar elimination.
6.5.7 Increase the capacity in BCC
Strengthen the capacity of the staff, health workers and volunteers at the district and sub district
level to plan manage and implement social mobilization and behaviour change strategies.
Orientation for health & family planning field staffs such as HA, FWA, AHI, HI, SI, FPI, NGO
workers like health volunteers (pusti apa & other volunteers). The sustainability and impact of
interventions would depend on the capacity of the providers. Motivation of the person who is
responsible for communication is a very important factor that determines the impact on the
audience. The non-verbal communication and the timeliness of communication determine the effect
that communication has on the audience.
6.5.8 Key to success in BCC
• Elaborate plans for communication and sharing of knowledge and information, which
should be an integral part of the strategy.
• Behaviour change communication should be implemented only when the product is
accessible, available and affordable to the target audience
• The strategic plan for communication should be implemented in a pilot situation. It should
be revised based on the pilot experience.
• Involvement of the community is important for the success of Kala-azar elimination
programme. The poor communities need to be involved maximally in the elimination
programme.
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6.6 Key messages to achieve the behaviour change objectives
6.6.1 Early Diagnosis and complete treatment of Kala-azar
Since the countries are committed to the elimination of Kala-azar, the diagnosis and treatment of
Kala-azar should be provided free in the government, private and NGO sectors. Since the disease
affects the poorest segments, the programme should also consider covering the costs of transport,
compensation for the loss of wages and food costs for the patient and at least one attendant if the
patient is hospitalized. These measures provided in the form of a package are likely to contribute to
completion of treatment.
6.6.2 Community co-operation to ensure uniform and complete coverage with IRS
IRS continues to be a very effective strategy in reducing the transmission of the disease provided
that the insecticide is of good quality and all surfaces in the dwellings are sprayed with the
insecticide. For the latter, full participation and cooperation of the households is necessary.
• All the households should know the schedule for spraying of the households so that they can
prepare to participate when the spraying team arrives for IRS
• All the surfaces to be sprayed should be cleared for them to be sprayed
• The cattle sheds should be sprayed thoroughly
• Do not wash or mud plasters the sprayed surface for a period of 8-10 weeks after the spray.
This will ensure maximum effect of the insecticide
• Keep the household and the surroundings clean especially the areas where there is dampness
• Keep foods and food products covered and make sure that these are not sprayed with
insecticides.
6.6.3 Reduce the human vector contact
This is the responsibility of all the individuals in the affected areas. People living in Kala-azar
endemic areas should adopt suitable measures that reduce or eliminate human vector contact. Key
messages should be developed with the following content.
• The contact with the vector most often occurs between dusk and dawn. Therefore protect
yourself from a bite especially between dusk and dawn.
• Wear long sleeves clothes to prevent the sandfly from biting.
• Use mosquito repellants to keep the sandfly away.
• Sleep under bed nets that are treated with insecticides and have the appropriate mesh size to
prevent the sandflies from entering the nets.
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6.6.4 Micro environmental Control
Micro-environmental control and management is the responsibility of each household, which can be
achieved through their participation. Keeping the households and the surroundings clean will help
to reduce the breeding sites for the sandflies. This should be done as a regular drill once a week.
Guidance should be provided by the health workers and health volunteers and supervised by staff
responsible for the elimination of Kala-azar.
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Learning Unit – 7
Case Summary
Case summary –1
A 22-year-old three months pregnant woman from Gazipur presented with the complaints of fever
for 2 months and a single episode of nasal bleeding. Fever was intermittent, having no diurnal
variation and sometimes associated with chills. There was no cough, haemoptysis, abdominal pain,
dysuria or jaundice.
Clinical examination showed moderate anaemia, temperature 1010F, pulse 128/min, blood pressure
150/60 mm Hg, and respiratory rate 26 per minute. There was no jaundice or lymphadenopathy.
Body weight was 56 Kg. Hepatosplenomegaly was present with splenic enlargement more than that
of liver. There was no ascites. Fundal height of uterus was 14 weeks size. Cardiovascular and
respiratory systems were normal.
Investigations revealed Hb-8gm/dl, total count of WBC- 8000/cmm with normal differential counts,
serum albumin-3.2gm/dl, serum globulin-1.8gm/dl, and albumin-globulin ratio was 1.8:1. Renal and
liver function tests were normal. USG of pregnant uterus showed 14 weeks of viable pregnancy.
DAT for Kala-azar was strongly positive and rapid diagnostic test (rK39) for Kala-azar was found
positive. Detection of LD body was not attempted from bone marrow or spleen because of poor
general condition.
Inj.SAG 20 mg/kg/day was started and the patient was closely monitored. She became afebrile on
6th day. Splenic size had been regressing. She was haemodynamically stable and ECG finding was
normal. On 27th day of treatment with SAG she complained about lower abdominal pain and started
having blood stained vaginal discharge. On the next day a dead macerated foetus was delivered
spontaneously. Rapid diagnostic test for Kala-azar (rK39) was done on foetal umbilical cord blood
and found positive for rK39 for KA. SAG was continued for 28 days. There was no other
complication. During discharge she was afebrile, having had non-palpable liver and spleen. Her
blood count, liver function test and renal function tests were normal.
Picture to be inserted
97
Case summary –2
A 25-year-old multiparous housewife from Chandpur, was admitted into DMCH with the
complaints of fever, left upper abdominal mass and progressive weight loss for 3 months. Fever was
low grade, intermittent and had no diurnal variation. She noticed her abdominal mass was gradually
increasing in size for which she felt dyspepsia like symptoms. Her appetite was decreased.
On clinical examination she was moderately anaemic, temperature was 1040F, pulse was 110/min,
blood pressure was 120/70 mmHg, and respiration was 24/min. There was non-tender
hepatosplenomegaly. Spleen was more enlarged than liver cardiovascular system and respiratory
system were normal.
Investigations revealed Hb-7gm/dl, total count of WBC was 7,700/cmm with normal differential
counts; ESR-70mm in 1st hour; serum albumin-I .9gm/dl, globulin-9.8gm/dl, albumin-globulin
ratio-0.2: 1; and random blood glucose-4.2mmol/L Liver function test, renal function test and upper
GI endoscopy was normal. Rapid diagnostic test (rK39) and DAT for Kala-azar was strongly
positive. Both intracellular and extracellular LD bodies were seen in splenic aspirate.
Inj. SAG was given 20mg/kg/day for 30 days and some parameters were observed during follow up
in a pre-designed chart (i.e. pulse, BP, temperature, weight, hepatic and splenic size, ECG and Hb),
Her temperature came to the base line on 12th day of SAG. She gained 3 kg weight. Hepatic and
splenic size were decreased. Hb increased. After completion of treatment LD body was not found in
splenic aspirate. After one-month stay in the hospital she was discharged as apparent cure from
Kala-azar and advised to come after 1 month for follow up. During the follow up visit she had
blurring of vision. Her body weight increased, hepatic and splenic sizes were decreased further.
There was refractory error in her both eyes and some pigmentary changes in the retina. Hb was 11.1
gm/dl; serum albumin was 5.0gm/dl and serum globulin was 4mg/dl. Liver function test and renal
function tests were normal. No LD body was seen on bone marrow examination. But she was found
to have diabetes mellitus. Fasting blood glucose was 19.5mmol/L and two hours after 75gm glucose
was 24mmol/L. Blood sugar was controlled with short acting insulin.
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Case summary –3
A 15-year-old schoolboy from Narsingdhi, presented with the complaints of occasional bleeding
from different parts of the body (nose, gum and per rectal) for 2years; feeling of abdominal mass
and progressive weight loss for 6 months. He had no history of fever, cough, haemoptysis, or
jaundice. His father had pulmonary tuberculosis and was treated with anti-TB drugs 6-months
regimen but he stopped 1 month prior to admission as no improvement had occurred.
On clinical examination he was mildly anaemic, weighed 29kg, temperature was 980f, pulse 80/min,
and blood pressure was 90/60 mmHg. There was generalized lymphadenopathy. Abdominal
examination revealed non-tender hepatosplenomegaly. The lungs and heart appeared normal.
Investigations revealed Hb-9gm/dl; total WBC count 6000/cmm with normal differential counts;
ESR was 120 mm in 1st hour; platelet count-3, 00,000/cmm; bleeding time and clotting time were
normal. Serum albumin-3.4gm/dl globulin; and albumin-globulin ratio was 0.4:1. Liver function test
and renal function test were normal. Chest X-ray was normal, and MT test revealed 04mm
indurations. Rapid diagnostic test (rK39) and DAT for Kala-azar were strongly positive. Splenic
aspiration revealed plenty of LD bodies. Treatment was started with inj. SAG 20mg/kg/day.
Thereafter patients’ body weight increased, hepatic and splenic size gradually began to regress but
his physical well-being was not improved. He had nasal bleeding on 7th day and skin rash on 10-12th
day of treatment. On the 14th day he had loose motion with single episode of malena and
subsequently developed abdominal pain, arthraliga and myalgia. At that time serum amylase was
378 U/L and plain X-ray abdomen revealed normal. On the 17th day of treatment hr was found
icteric, developed oliguria and became restless. His pulse was feeble and blood pressure was
70/50mmHg. ECG showed junctional tachycardia. Patient was transferred to CCU for cardiogenic
shock where he developed ventricular tachycardia and subsequently electromechanical dissociation.
CPR was given but he did not survive. He died on 17th day of treatment with SAG.
ECG tracing of the patient (case-3) following day 15 and 17 after initiation of sodium
stibogluconate. The patient developed fatal ventricular tachycardia on day 17.
99
Key References
1. Kala-azar – Diagnostic Treatment and Recording Charts – A Training Module, DGHS
& IEDC&R, 1995.
2. Zoonotic Disease of Public Health Importance – A Manual of National Institute of
Communicable Disease, India, 2000.
3.. Laboratory Diagnosis of Kala-azar with Director Agglutination Test –A Training
Module for Laboratory Technicians, IEDC&R and Malaria and Parasitic Disease
Control Unit, DGHS, 1996.
4. Manual on Visceral leishmaniasis –WHO publication, 1996.
5. Medical Insects and Arachnids. Edited by R.P. Lane & R.W. Crosskey, Published by
Chapman and Hall, London, UK, 3rd Edn. 2003, ISBN 0412 400006.
6. Medical Parasitology, N.C Dey, T.K Dey, M.Dey Sinha, 10 Edition 1992
7. Park – Community medicine,18 th edition,2005
8.K.M.Rashid,Mahmudur Rahman,Sayeed Hyder,4 th edition,2004
9. KD Chatterjee, Parasitology, Protozoology and Helmintheology, twelfth edition 1981.
10. Monica Chessbrough, Medical laboratory Manual for Tropical countries, Vol, 2nd Edn.
ELBS publication, 2000.
11.Indian Paediatris,2005:42:523-526
12.The Diagnosis and management of severe malaria------Learner
100
Annexure-1
Developmental stages of L. donovani in man & sandflyDevelopmental stages of L. donovani in man & sandfly
Reservoir of infection
in Mediterranean area and in China
Spleen
Liver
Bone marrow
Distribution of L. donovani in Kala-azar
Infection of sandfly
Infection of man
A section of pharynx of
Phlebotomus argentipes
101
Annexure-2
Methods of diagnosisMethods of diagnosis
102
Annexure-3
Collection of Blood Sample:
The result of laboratory test depends upon the quantity, quality, and nature of the specimen. The
collection, processing, transpiration and preservation of sample are very
vital steps in laboratory diagnosis of disease.
There is risk of getting some infection from the blood of some people who carry an infectious agent
in their blood even if they do not appear to be sick. Blood from patients with viral hepatitis, AIDS
and rarely malaria may contaminate out injuries or wounds. Accidental pricking with a
contaminated needle or lancet used for blood collection may also be a hazard. However, this risk
can be reduced to a minimum or avoided by taking some precautionary measures. The following
points should be observed while collecting blood samples.
Required quantities of specimen should be collected.
Sterile equipment must be used and aseptic precautions should be taken to avoid
contamination.
Specimen should be dispatched as soon as possible.
Specimen may be preserved in the refrigerator in case of delay.
All specimen should be labeled accurately.
Protecting gloves should be used during collecting and handling of blood samples.
Contamination of fingers and hands should be avoided.
Cut injuries or abrasions on the fingers/ hands should be covered with adhesive dressing.
Laboratory workers should be vaccinated against hepatitis-B virus.
Blood samples may be collected either through venepuncture or by the finger prick
technique.
103
Annexure 4
Serological TestsSerological Tests
Direct agglutinationDirect agglutination
Complement fixationComplement fixation Indirect immunoIndirect immuno--
fluorescencefluorescence
Crude soluble antigenCrude soluble antigen rK39 Recombinant antigenrK39 Recombinant antigen
KY62KY62
P2 acid ribosomal proteinP2 acid ribosomal protein
Chimeric antigenChimeric antigen
Immunochromatographic Dip stick testImmunochromatographic Dip stick test
ImmunoblotImmunoblot
ELISAELISAAntigen specific IgG3Antigen specific IgG3
104
Annexure 5
SOP: Bone Marrow Aspiration
1. Purpose: Bone marrow aspirate will be done for parasitological diagnosis of Kala- azar
2. Applicability:
• Cure assessment/failure assessment where splenic aspirate will not be possible
3. Investigation to be done prior to bone marrow aspiration:
• Platelet Count
• Prothrombin Time
4. Where to do?
• Level III (Medical college hospital)
5. Who will do it?
a. Assistant Registrar or Indoor Medical officer
6. Instruments needed for bone marrow aspiration:
• Hand gloves
• 10 ml disposable syringe
• Glass slide
• Slide box
• Local cleaning materials like Povidone iodine and spirit,
• Kidney tray
• Drum for sterilized artery forceps, Gauge pieces. etc.
7. Emergency Medicine:
• Hartman’s solution/ DNS 1000 ml
• I V Canula
• Inj. Haemosin 5ml ampoules
8. Antibiotic: Inj. Ceftriaxone 1gm
9. Procedure:
i. Take inform consent
ii. Reassure the patient and describe the procedure in brief
iii. Place the patient in supine position
iv. Remove cloths from the site of puncture
v. Wash hands and wear sterile gloves
vi. Assess the manubrium sternum and its thickness
vii. Clean area with Povidone and then with spirit
viii. Let the area dry
ix. Inject 2% Lignocaine around the site of puncture
x. Fix the needle at estimated half thickness of the sternum
105
xi. Introduce the bone marrow needle gradually up to the guard
xii. Take out the stillate and attach a 5 ml syringe
xiii. Draw the bone marrow aspirate with the syringe
xiv. Withdraw the needle, press the puncture site and fix with sterile gauge with
micropore.
xv. Advise patient to lie for half an hour at site of aspiration.
xvi. Prepare smear on glass slides and let them dry in air for 5-10 minutes
xvii. Send the slides to Microbiology Department of Medical College for staining and
microscopy
9. Management of complication
a. Marked pain :
• Tab. Paracetamol 500 mg
• Tab. Ranitidine 150 mg
Smear of marrow fluid obtained by sternal punctureSmear of marrow fluid obtained by sternal puncture
L. Donovani
(Amastigote)
106
Annexure 6
SOP: Splenic Aspiration
1. Purpose: Splenic aspirate is done for parasitological diagnosis of Kala- azar
2. Applicability:
• Diagnosis during screening
• Cure assessment/failure assessment
3. Investigation to be done prior to Splenic aspiration:
• Platelet Count
• Prothrombin Time
4. Where to do?
• It will be done in Level III (Medicine Unit of Government Medical College
Hospital)
5. Who will do it?
• Assistant Registrar or Indoor medical officer.
6. Instruments needed for splenic aspiration:
• Hand gloves
• 10 ml disposable syringe
• Glass slide
• Slide box
• Local cleaning materials like Povidone and spirit,
• Kidney tray
• Drum for sterilized artery forceps, Gauge pieces. etc.
7. Emergency Medicine:
• Hartman’s solution/ DNS 1000 ml
• I V Canula
• Inj. Haemosin 5ml ampoules
8. Antibiotic: Inj. Ceftriaxone 1gm
9. Procedure:
i. Take inform consent
ii. Reassure the patient and describe the procedure in brief
iii. Place the patient in proper position (supine or right lateral)
iv. Remove cloths from the site of puncture
v. To wash hands and to wear sterile gloves.
vi. Clean area with Povidone and then with spirit
vii. Let the area dry
viii. Place two draw sheets one on chest and the other on the abdomen
107
ix. Instruct the patient to take a deep breath and hold it until aspiration is not complete
x. If spleen is sufficiently enlarged to aspirate intra-abdominally
xi. In case of small spleen or when just palpable spleen then to do intercostal aspiration
between 9th & 10th intercostals spaces.
xii. First to pierce the skin with needle in proper site and to produce negative pressure in
the syringe.
xiii. Then to introduce the needle along the long axis of the spleen quickly
xiv. Draw a little amount of splenic materials.
xv. Withdraw the needle, press the puncture site and fix with sterile gauge with
micropore.
xvi. Advise patient to lie on Rt. lateral position at least for one hour at site of aspiration.
xvii. Then transfer the patient to the bed and watch for vita signs for an hour.
xviii. Prepare smear on 6 glass slides and let them dry in air for 5-10 minutes
xix. Send the slides to Microbiology Department of Medical College for staining and
microscopy
10. Management of complication
b. Marked pain :
• Tab. Paracetamol 500 mg
• Tab. Ranitidine 150 mg
c. Signs of intra-abdominal hemorrhage (Rapid pulse, Low BP, Abdominal distension/
tenderness
• Hartsol solution/ 5% DNS – 1000 ml
• Haemolysin 1 ample I/V slowly
• Observe vital signs half hourly
d. Local Infection: Cap. Cephradine/ Flucloxacilline: 500 mg (1+1+1+1) for 5 days.
e. Impending shock: According the protocol of hypovolemic shock.
f. Peritonitis: Antibiotics and surgical consultation
108
Smear from material obtained by spleen punctureSmear from material obtained by spleen puncture
L. Donovani
(Amastigote)
109
Annexure 7
SOP: Staining and Microscopy of Splenic Aspirate/Bone marrow
1. Purpose: Parasitological diagnosis of Kala- azar by examining of splenic aspirate or bone
marrow smear after staining
2. Applicability:
• Staining of smear
• Microscopy of stained smear
3. Where to do?
• Microbiology Department of Government Medical College
4. Who will do?
a. Staining will be done by Medical Technologist (Lab) of Microbiology Dept. of
Medical College
5. Transfer of slides to Microbiology Department
a. For each patient slides of smear will be transferred to Microbiology Department by
Asst. Registrar of Medicine Unit
6. Staining and Microscopy
a. All slides will be stained by Leishman stain
b. All slides will be examined by the Microbiologist under oil emersion lens
c. At least 1000 fields will have to be examined
d. A representative slide will be used for parasitological score
7. Parasitological score (by microscopic evaluation): |__| (score as below)
Score 0 = 0 amastigote per 1,000 fields
Score 1 = 1-10 amastigotes per 1,000 fields
Score 2 = 1-10 amastigotes per 100 fields
Score 3 = 1-10 amastigotes per 10 fields
Score 4 = 1-10 amastigotes per field
Score 5 = 10-100 amastigotes per field
Score 6 = >100 amastigotes per field
8. Reporting
a. Report will have to be prepared in the prescribed form
b. Report will have to be preferably provided on the same day
110
Annexure 8
Promastigote forms from culturePromastigote forms from culture
111
Annexure 9
PCR Detection of PCR Detection of L. donovani L. donovani from blood samplefrom blood sample
A B C D E F N M H I J K L P
+ + + + + + - M + - + + + +
Annexure 9
PCR Detection of PCR Detection of L. donovani L. donovani from bone marrowfrom bone marrow
A B C D E F G H I J K L N P
+ + + + + + + + + + + + - +
112
Annexure-10
Pharmacological Properties of Miltefosine:
1. Pharmacodynamic properties
Pharmacotherapeutic group: Antiprotozoal, ATC code: P01 CX
Miltefosine has a marked direct antileishmanial activity in vitro and in animal models. The mode of
action of miltefosine in leishmaniasis is unknown. Among others, miltefosine can inhibit
metabolism of phospholipids.
2. Pharmacokinetic properties
Miltefosine is well absorbed from the gastrointestinal tract after a single oral administration
(absolute bioavailability: 82 and 94% in rats and dogs) but absorption occurred very slowly with
tmax values from 4 to 48 h. Miltefosine is widely distributed into the body. After multiple oral
administrations to humans the terminal plasma half-life ranged between 150 h and 200 h (6 to 8
days).
In man the absolute bioavailability as well as the clearance and the volume of distribution were not
determined as miltefosine has hemolytic activity and thus cannot be given intravenously.
No oxidative metabolism by different cytochrome P450 isozymes was observed. Metabolism by
phospholipase D produced choline. Human hepatocytes showed metabolism with choline as major
metabolite.
113
Annexure-11
Other drug treatment of Kala-azar
• Amphotericin
Amphotericin B - A suitable regimen is 1 mg/kg by intravenous infusion daily until a total dose of
20 mg/kg has been given.. The major side effect of Amphotericin B is renal impairment and renal
function should be monitored weekly during treatment. Renal impairment can be reduced by
hydrating the patient with an infusion of normal saline. If a rise in urea and creatinine occur, the
interval between doses should be lengthened. Other side effects include fever and anemia.
• Paromomycin (Aminosidine)
Aminosidine (paromomycin; Gabromicina, Farmatalia). Aminosidine is an anti-leishmanial
aminoglycoside, which may be synergistic with pentavalent antimony. A suitable regime is
pentavalent antimony 20mg/kg daily for 30 days plus Aminosidine at 15 mg/kg daily for 30 days.
The two drugs are given by separate injections in two separate sites. Aminosidine may cause renal
impairment and urea or creatinine should ideally be monitored weekly during treatment. It might
also affect the auditory nerve and cause high-tone deafness.
114
Annexure 12
Instructions for the spray squad members (Do’s and Don’ts)
Dos for spray squad members
• A simple flyer should be provided to each member of the spray squad. This should be in
simple local language with appropriate illustrations.
• Wash your hands thoroughly with soap and water after preparing the insecticide spray. This
is to be repeated every time the spray operation is stopped. Washing of hands thoroughly
with soap and water is advised when the team takes a lunch or tea break.
• The personal protection comprising of apron, gloves, mask and goggles should be worn
during the insecticide spray.
• Avoid direct contact of the insecticides with eyes or skin. If this happens wash the skin
coming in contact and adjacent skin thoroughly with soap and water. Eyes should be
flushed repeatedly with clean water for a period of at least 5 minutes or 10 times to protect
yourself against any harmful effects of the insecticides.
• If irritation persists even after thorough washing, seek medical advice.
• If any member of the spray team suffers from any symptoms while the spraying operations
are ongoing, medical attention should be sought without any delay.
Don’t’s for spray squad members
• Do not eat or drink while doing the insecticide spraying
• Do not delay seeking medical help if there is irritation in the eyes or skin or cough or
breathing problem following the insecticide spraying
• Do not smoke or while doing insecticide spraying
• Do not perform spraying without wearing personal protection equipment
115
Annexure-13
Spraying technique
The suspension of DDT for spraying or other insecticide should be prepared when the team is ready
to start the spraying. The suspension should be prepared correctly so that sufficient quantities of the
insecticide are sprayed to be effective. Prepare 10 liters of the suspension at a time. This is enough
for covering 500 meters square surface area. Therefore this will be sufficient for 6-8 households for
Kala-azar and 3-4 households for malaria. If the village is high endemic for malaria it is advised
that the norms for malaria should be followed. This will also be effective against Kala-azar.
Place the required quantities of DDT wettable powder or other insecticide in a 15-liter bucket as per
instructions. Add volume of water with a mug that is considered adequate to make a paste of DDT
or other insecticide as appropriate . Do not put too much water at this stage. Once the paste is made
then pour water on the paste and keep mixing vigorously to make a uniform suspension. Add
measured volume of water i.e. 10 liters. After this procedure filter the solution through a clean cloth
to remove any particulate matter. Any particulate matter will block the nozzle of the spray
pump. This will cause difficulty in spraying the surface with the insecticide.
The barrel of the spray pump is placed in the bucket containing the spray suspension. One person
operates the pump and the other is responsible for the spray. If a compression pump is used it can be
operated by one person. The spray lance should be kept 45 cms away from the surface to be
sprayed. The swath should be parallel. It is applied in a vertical swath about 53 cms wide. There
should be an overlap of about 7.5 cms between two swaths. Spraying should be done from the top
downwards. The top should be about 6 feet from the ground. The spray should not drip on to the
floor.
The discharge rate should be 740-850 ml per minute. The person who is responsible for pumping
the material should give 20-26 strokes per minute with 10-15 cms plunger movement at a pressure
of 10 pounds per square inch. Spraying into a bucket for one minute and measuring the discharge
rate per minute helps to ensure that the discharge rate is satisfactory. If the discharge rate exceeds
850 ml minute then the nozzle should be rejected.
A blockage in the nozzle is a frequent problem. The nozzle cap should be removed by unscrewing it
and replaced by a new nozzle, which is patent. The blocked nozzle should be kept immersed in
water for a few hours and then cleaned with a fine wire.
The unused insecticide should be disposed off safely as per the guidance provided. The buckets that
were used should be cleaned properly ensuring safe disposal of the waste to ensure that it does not
116
contaminate the environment. The details of safe disposal of insecticides are included in another
section.
The deposits on the wall should be uniform and no areas should be skipped. This is an indication of
good spray. The supervisor should check the quality of the spray. This is easy to do in the case of
DDT since DDT leaves white deposits after the spraying has been done.
It takes about 3 minutes to spray about 150 sq meters area. This is the average size of a dwelling in
rural areas of India. The size of the house to be sprayed can vary from country to country. The
instructions should be accordingly adjusted in other countries.
There are always some households that are not covered in the first round. These should be covered
under subsequent mopping up round on the same day or on a predecided different day.
117
Kala-azar & PKDL
Treatment
Chart
Treatment A
(First line treatment for Kala-azar)
Miltefosine
Dose: 2.5mg/kg body weight, in two divided dose by mouth in the morning and evening after
meal for 28 days.
In case of missed doses, the scheduled 28 doses may be taken within a period of 35 days. The daily dose
should never exceed the recommended amount.
The doses should be calculated as follows:
i) >12 years and weighing ≥25kg: 100 mg. ( cap 50 mg in morning and 50 mg in evening)
ii) >12 years but weighing <25kg: 50 mg. (cap 50 mg in the morning)
iii) 2-12 years: 2.5 mg/kg body weight. ( in two divided dose, not exceeding 50mg/day)
If an exact dose cannot be administered, the closest 10 mg increment will be chosen at the dose. Rounding will be
done as follows:
❖ If the calculation comes to <5 – to round dose down.
❖ If the calculation comes to >5 – to round the dose up.
Treatment B (If Miltefosine is not available or
in KATF or contraindication)
Sodium Antimony Gluconate (SAG)
Treatment C (2nd line Rx for Kala-azar)
Amphotericin-B
deoxycholate (non
liposomal)
Dose: 1 mg/kg body wt daily
IV (in 5%Dextrose solution)
for 20 days.
Route: IV
Duration: 20 days
Amphotericin B (Liposomal)
Dose: 3mg/kg/day
Route: IV
Duration: 5 days
Indication:Kala-azar treatment
failure(KATF) and in case of
pregnancy.
Treatment D
( Rx for PKDL Cases)
a) Sodium Antimony
Gluconate (SAG)
Dose: 20 mg/kg body wt daily
for 20 days per cycle
Route: IM/IV
Duration: Six cycles with 10
days interval between cycles
b) Amphotericin-B
Dose: 1 mg/kg body wt daily
IV(in 5%Dextrose solution)
for 15 days. Six cycles with 10
days interval between cycles
Route: IV
c) Amphotericin B
(Liposomal)
Dose: 3mg/kg/day
Route: IV
Duration: 5 days, six cycles
with 10 days interval between
cycles.
Dose: 20 mg/kg body wt daily
Route: IM/IV
Duration: 30 days
118
rK-39
positive
DIAGNOSIS
AND
MANAGEMENT
CHART
▪ Fever or
▪ H/O fever for> 2
wks
Yes Is there any
evidence of another
disease other than
KA?
No
▪ Splenomegaly
▪ Weight loss
▪ Anaemia
Yes
rK-39 positive
Record as Kala-azar and
use Treatment A or B
according to availability
Is the patient
pregnant?
Yes
Record as KA with
pregnancy and use
Treatment C
Was complete treatment with
Miltefosine or SAG done
within last year?
Yes
Hypopigmented patches(macule)
without loss of sensation with or
without
▪ erythematous patch(papule)
▪ sub-cutenous nodule
▪ fever or H/O KA
Yes
rK-39 positive
Record as PKDL
and use Treatment D
Record as
KATF and use
Treatment C
119
Pictures of PKDL patients
Nodular
Papular
Macular
120
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