Superfici antibatteriche in rame:

cosa ci insegnano i clinical trial Marco Crespi – Istituto Italiano del Rame

Congresso Nazionale SIMPIOS, Rimini, 9-11 maggio 2016

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Indice

1. Rame: test di laboratorio

2. Rame: i clinical trial

3. Conclusioni

4. Rame antibatterico: approfondimenti e bibliografia

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1. Rame: test di laboratorio

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Il rame contro i batteri

La letteratura scientifica cita la capacità del rame di inattivare o eliminare diversi

tipi di batteri, funghi e virus nocivi:

• Acinetobacter baumannii • Legionella pneumophilia

• Adenovirus • Listeria monocytogenes

• Aspergillus niger • MRSA (con E-MRSA)

• Candida albicans • Poliovirus

• Campylobacter jejuni • Pseudomonas aeruginosa

• Clostridium difficile • Salmonella enteriditis

• Enterobacter aerogenes • Staphylococcus aureus

• Escherichia coli (ceppo O157:H7) • Bacilli della tubercolosi

• Helicobacter pylori • VRE

• Influenza A (ceppo H1N1) • ….

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2. Rame: i clinical trial

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Rame antibatterico e clinical trial

Un po’ di storia

1) 1983: le maniglie in ottone ospitano meno batteri

2) 2008: al Selly Oak Hospital (UK), il primo importante clinical trial

3) 2010: Asklepios Clinic (D), si osserva una diminuzione delle infezioni

www.europeanhospital.com: “Copper Fittings beat bacteria”

T.J. Karpanen, A.L. Casey, P.A. Lambert, B.D. Cookson, P. Nightingale, L. Miruszenko, T.S.J. Elliott: ”The antimicrobial efficacy of copper alloy

furnishing in the clinical environment: a crossover study”

P.J. Kuhn: “Doorknobs: a source of nosocomial infection?”

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Clinical trial USA (3 ospedali)

(2007-2011)

Tre ospedali: Medical University of South Carolina (6 stanze); Memorial

Sloan Kettering Cancer Center (6); Ralph H. Johnson Veterans

Administration Medical Center (4).

Terapia intensiva: sponde dei letti; tavolini mobili; braccioli delle poltrone;

piantane porta-flebo. Monitor, pulsanti dei dispositivi di chiamata, mouse.

Durata complessiva: dic.2007 – giu.2011 (in tre fasi)

Da: H.T. Michels, C.W Keevil, C. Salgado, M.G. Schmidt: “From Laboratory research to a clinical trial: copper alloy surfaces kill bacteria and

reduce Hospital-acquired infections”

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Maximum 2 lines Clinical trial USA (3 ospedali)

Risultati seconda fase

Batteri isolati

nelle stanze

Somma sui 6 oggetti, media (cfu/100cm2)

rame 2.521

non rame 14.813

riduzione: 83%

Sponde dei letti Valori medi (cfu/100cm2)

rame 366

non rame 6.471

Da: Michael G Schmidt, Hubert H Attaway,e al.: “Sustained Reduction of Microbial Burden on Common Hospital Surfaces through Introduction of

Copper”

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Maximum 2 lines Clinical trial USA (3 ospedali)

Risultati seconda fase

Da: Michael G Schmidt, Hubert H Attaway,e al.: “Sustained Reduction of Microbial Burden on Common Hospital Surfaces through Introduction of

Copper”

Distribuzione

(cfu/100cm2)

0

0-250

250+

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Maximum 2 lines Clinical trial USA (3 ospedali)

terza fase

Oggetto Rame

(tot: 294)

Non rame

(tot: 320)

No HAI o colonizzazione 273 (92,86%) 279 (87,19%)

HAI e/o colonizzazione 21 (7,14%) 41 (12,81%)

• Solo HAI (1) 10 (3,40%) 26 (8,12%)

• Solo colonizzazione (2) 4 (1,36%) 12 (3,75%)

Dati su 614 pazienti;

durata: 11 mesi

(HAI: Healthcare Acquired Infections) (1) P= 0.013 (2) P= 0.063

37 pazienti hanno contratto un’infezione nosocomiale durante i prelievi:

89% delle infezioni con > 500 cfu/100 cm2

Da: Cassandra D. Salgado ed al.: “Copper Surfaces Reduce the Rate of Healthcare-Acquired Infections in the Intensive Care Unit”

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Maximum 2 lines Clinical trial USA (3 ospedali)

terza fase

Da: Cassandra D. Salgado ed al.: “Copper Surfaces Reduce the Rate of Healthcare-Acquired Infections in the Intensive Care Unit”

Spostamento di oggetti durante la degenza:

Rame: 137 pazienti su 294 con tutti i 6 oggetti in rame

Non rame: 270 pazienti su 320 con nessun oggetto in rame

Doppio cieco non è possibile. Come valutare i risultati?

• Elemento di controllo standard in ogni stanza: la pediera del letto. Nessuna

differenza significativa tra le stanze in rame e non-rame (2.786 e 2.388

cfu/100 cm2)

• Elementi in rame: montati 9 mesi prima della raccolta dei campioni

• Il personale ospedaliero non era a conoscenza dell’inizio

Il tasso di infezioni nosocomiali non è variato lungo il periodo

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Maximum 2 lines Clinical trial Cile

Reparto pediatrico

Hospital de Ninos Roberto del Rio, Santiago: 16 stanze (8+8) nei reparti di

terapia intensiva e intermedi

Camere con anche con più 2 letti

Durata: 12 mesi (in due fasi)

Da: M.G. Schmidt; B. von Dessauer; C. Benavente; D.Benadof; P. Cifuentes; A. Elgueta; C. Duran; M.S. Navarrete: “Copper Surfaces are

Associated with Significantly Lower Concentrations of Bacteria on Selected Surfaces within a Pediatric Intensive Care Unit”

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Maximum 2 lines Clinical trial Cile

Reparto pediatrico

Oggetti: sponde dei letti, culle, rubinetti, piantane portaflebo e banchi di

lavoro.

Tre leghe di ottone (rame 65÷85%)

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Reparto pediatrico

Stanza n. oggetti val. medio

cfu/100cm2

val. mediano cfu/100cm2

Rame 668 172 0

Non rame 652 1381 574

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Reparto pediatrico

”This study showed that through a reduction to burden,

through this intervention in the PICU, the HAI rates

decreased from 13.0 per 1,000 patient days for patients

treated in the control settings to 10.6 per 1,000 patient days

for patients treated in rooms with a limited number of copper

objects [….].

Although the relative risk reduction failed to achieve

statistical significance, we are encouraged that through

reducing burden with copper surfaces, we were able to

observe fewer infections among patients within the PICU.”

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Maximum 2 lines Clinical trial USA e Cile

Prima e dopo l’applicazione del rame

Stanza Sponde dei letti nelle stanze

«non rame»

Sponde dei letti nelle

stanze «rame»

Prima fase

(«pre-

intervento»)

Seconda fase

(«intervento»)

Riduzione

(%)

Seconda fase

(«intervento»)

Riduzione

(%)

MICU (1)

(USA)

17.336 6.471 - 63 366 - 98

PICU (2) (Cile)

4.800 1.313

- 73 43 - 99

in cfu/100 cm2

(1) MICU = Medical Intensive Care Unit (2) PICU = Pediatric Intensive Care Unit

Come varia il carico batterico prima e dopo l’installazione degli oggetti in lega di

rame?

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Maximum 2 lines Clinical trial

….ma il rame, conviene?

• Quante infezioni avvengono

nel mio ospedale/reparto?

• Quanto costa una giornata

in ospedale al SSN?

• Quante infezioni

potrebbe evitare il rame?

• Quanto costano gli

elementi in rame?

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….ma il rame, conviene?

• Costo extra per i componenti in rame: 52 K$

• Infezioni evitate nelle stanze in rame: 14

• Durata della fase 3: 338 giorni

• Costo per trattare 1 infezione: 28,4 K$ (x14 = 397,6 K$)

• Costi evitati 397,6 K$ : 338 giorni = 1.176 $/giorno

Stima effettuata sui clinical trial USA:

Payback 52 K$ : 1176 $/giorno = 44,2 giorni

Da: H.T. Michels, C.W Keevil, C. Salgado, M.G. Schmidt: “From Laboratory research to a clinical trial: copper alloy surfaces kill bacteria and

reduce Hospital-acquired infections”

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Tom Elliott (microbiologo e vice-direttore):

“The cost of fitting out the trial ward (a 20-bed

general medical ward) was equivalent to the

cost of just one-and-a-half infections”

Ospedale “Selly Oak”, Birmingham (UK)

Clinical trial

….ma il rame, conviene?

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I risparmi con il rame:

il modello di calcolo YHEC

• Confronta i costi delle infezioni e dell’installazione dei componenti in rame per valutare il

payback

• Sviluppato dall’Università di York

•Scaricabile su www.antimicrobialcopper.org/uk/the-business-case

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I risparmi con il rame:

il modello di calcolo YHEC

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I risparmi con il rame:

il modello di calcolo YHEC, esempio

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I risparmi con il rame:

il modello di calcolo YHEC, esempio

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I risparmi con il rame: non solo ospedali

5 scuole elementari, con maniglie e corrimano in

ottone.

Dati presi dalla 40a settimana 2011 alla 15a del

2012). Si sono rilevate le assenze.

Efstathiou et al.: P370: Antimicrobial copper (Cu+) implementation and its influence to the epidemiological data in elementary school population.

Antimicrobial Resistance and Infection Control 2013 2(Suppl 1):P370.

“….Clinical morbidity index of

students was recorded at 36,01%

(average 5 schools), while in the

community the same period (2011-

2012) the rate was 48,8%..”

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3. Conclusioni

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Strategie per combattere le infezioni nosocomiali

www.cleanroomtechnology.com/news/article_page/Polish_health_authority_first_in_Europe_to_recommend_antimicrobial_copper_in_hospitals/117774.

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Strategie per combattere le infezioni nosocomiali

Oggi, quante superfici avete toccato e quante mani avete stretto?

Superfici antibatteriche

in rame e sue leghe

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4. Rame antibatterico: approfondimenti e bibliografia

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Bibliografia (clinical trial)

T.J. Karpanen, A.L. Casey, P.A. Lambert, B.D. Cookson, P. Nightingale, L. Miruszenko, T.S.J. Elliott: ”The antimicrobial efficacy of copper alloy

furnishing in the clinical environment: a crossover study” (Infection control and hospital epidemiology, Vol. 33 No.1, Jan. 2012, p. 3-9)

P.J. Kuhn: “Doorknobs: a source of nosocomial infection?” (Diagnostic Medicine, 1983)

www.europeanhospital.com: “Copper Fittings beat bacteria”

(www.european-hospital.com/en/article/6156-Copper_fittings_beat_bacteria.html)

A. Mikolay, S. Huggett, L. Tikana, G. Grass, J. Braun, D.H. Nies: “Survival of Bacteria on Metallic Copper Surfaces in a Hospital Trial” (Appl

Microbiol Biotechnol, (2010) 87:1875-1879)

H.T. Michels, C.W Keevil, C. Salgado, M.G. Schmidt: “From Laboratory research to a clinical trial: copper alloy surfaces kill bacteria and reduce

Hospital-acquired infections” (Health Environments Research & Design, 2015 Oct. 9(1): 64-79

P.A, Sharpe, M.G.Schmidt: “Control and mitigation of healthcare–acquired infections: designing clinical trials to evaluate new materials and

technologies” (Health Environments Research & Design, vol. 5, n.1 p.94-115)

Da: M.G Schmidt, H.H. Attaway,e al.: “Sustained Reduction of Microbial Burden on Common Hospital Surfaces through Introduction of Copper”

(Journal of Clinic Microbiology, 2012 50 (7): 2217)

C.D. Salgado, K.A. Sepkowitz, J.F. John , J.R. Cantey, H.H. Attaway, K.D. Freeman, P. A. Sharpe, H.T. Michels and M.G. Schmidt : “Copper

Surfaces Reduce the Rate of Healthcare-Acquired Infections in the Intensive Care Unit” ( Infection Control and Hospital Epidemiology , vol. 34,

No. 5, Special Topic Issue: The Role of the Environment in Infection Prevention (May 2013), pp. 479-486 )

Efstathiou et al.: P369: “Financial benefits after the implementation of antimicrobial copper in intensive care units (ICUs)”.

(Antimicrobial Resistance and Infection Control 2013 2 (Suppl 1):P369.)

Efstathiou et al.: P370: “Antimicrobial copper (Cu+) implementation and its influence to the epidemiological data in elementary school

population.” (Antimicrobial Resistance and Infection Control 2013 2(Suppl 1):P370.)

M.G. Schmidt; B. von Dessauer; C. Benavente; D.Benadof; P. Cifuentes; A. Elgueta; C. Duran; M.S. Navarrete: “Copper Surfaces are

Associated with Significantly Lower Concentrations of Bacteria on Selected Surfaces within a Pediatric Intensive Care Unit” (American Journal of

Infection Control, 44(2016) 203-9)

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Articoli in italiano e siti internet

M. Crespi: “Il rame contro le infezioni nosocomiali” (Progettare per la Sanità, mag. 2012)

M. Crespi: “Rame antibatterico: le conferme dagli ospedali” (Tecnica Ospedaliera, sett. 2010)

Istituto Italiano del Rame: “Superfici antibatteriche in rame: le F.A.Q.”

Wikipedia: “Superfici di contatto antibatteriche in rame”

www.copperalliance.it. “Applicazioni – Sanità”

www.slideshare.net: “ll rame contro i batteri” (presentazione)

www.antimicrobialtouchsurface.com

www.antimicrobialcopper.org

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www.antimicrobialcopper.org

Grazie per l’attenzione

Viale Sarca 336 – 20126 Milano.

Tel.: 02 89 30 1330

info@copperalliance.it - www.copperalliance.it

marco.crespi@copperalliance.it