blinded study synopsis format

7/28/2019 Blinded Study Synopsis format

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Exclusion

Criteria

Patients who meet any of the following criteria are not eligible to participate in this

study:

11.


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Test Product(s), Dose, Mode of Administration, and Duration of

Treatment

Duration of Study

Safety Variables

Efficacy Outcomes


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Statistical

Methods


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Appendix A Schedule of Study ProceduresStudy Visits

Study Day End of Therapy(EOT; 1-3 days

after last study

drug)

Test of Cure (TOC;7-14 days after last

study drug)

Late Follow-Upb

(28-32 days afterrandomization)

Study Procedure Screening

(within 24

hours of

Day 1)

1 2 3 4-10/14a

Informed consent (before

any study procedures)

X

Verify patient meets

inclusion and exclusion

criteria

X

Record relevant

medical/surgical history (5

years)

X

Record height (estimate if

necessary) and weight

X

Perform 12-lead

electrocardiogram

X

Determine NYHA class,

APACHE

X

Obtain chest x-ray or CT

scan

X

Randomize via IVRS X

Record most abnormal

pulse oximetry

X X X X X X

Record most abnormal

minute ventilation and FiO2

X X X X X X

Obtain partial pressure of

arterial O2 and blood pH

from arterial blood gas

X X X X X X


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analysis, if clinically

required

Determine CPIS and SOFA

scores

X X X X X X

Perform a physical

examination cX X X X X X

Record prior and/or

concomitant medications

X d X

X X X X X

Perform a chest

examination and VNP-

related signs and symptoms

assessment

X X X X X X

Record most abnormal vital

signs e

X X

X X X X X

Record temperature f X X

X X X X X

Obtain lower respiratory

tract or pleural fluid

microbiological specimensg

X X X X X X X (on-site visit only)

Collect blood sample for

microbiology h

X X X X X X (on-site visit only)

Collect urine sample

(urinalysis and Legionella

antigen)

X

Collect sample for

pregnancy test i

X


procalcitonin

X X X X j X

Collect blood samples for

chemistry and hematology

panels

X X X X X X X (on-site visit only)

Collect blood samples for

PK analysisk

X X X


coagulation panel

X

Calculate PT or INR; X


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Child-Pugh; estimate CLcr

Administer study drug X

l

X X X

Select or re-evaluate gram-negative adjunctive therapy

based on microbiology and

susceptibility results

X X X X

Determine Investigators

assessment of response

X X

Determine survival status X

Assess adverse events

(pretreatment, treatment-

emergent, or ongoing)

X X X X X X X X


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Abbreviations:

blinded study synopsis format

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