Randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy of polyhexanide for topical decolonization of MRSA carriers.
OBJECTIVE
The objective of this study was to evaluate the efficacy of polyhexanide (Prontoderm(®)) in eliminating MRSA carriage.


METHODS
In a 1900 bed teaching hospital, MRSA-colonized patients were randomized into a double-blind, placebo-controlled superiority trial between January 2011 and July 2014. Patients were treated with either polyhexanide or placebo applied to the anterior nares (thrice daily) and skin (once daily) for 10 days. The primary outcome was MRSA decolonization at day 28 (D28) after the end of treatment assessed by ITT responder and PP analyses (microbiological follow-up ± 7 days and topical treatment ≥ 5 days). Secondary outcomes included safety, emergence of resistance and MRSA genotype changes. Registered trial number ISRCTN02288276.


RESULTS
Of 2590 patients screened, 146 (polyhexanide group, 71; placebo group, 75) were included. ITT analysis showed that 24/71 (33.8%) patients in the polyhexanide group versus 22/75 (29.3%) in the placebo group were MRSA-free at D28 (risk difference, 4.5%; 95% CI, -10.6% to 19.5%; P = 0.56). PP analysis confirmed the results with 19/53 (35.8%) decolonized polyhexanide-treated patients versus 17/56 (30.4%) in the placebo arm (risk difference, 5.5%; 95% CI, -12.2% to 23%; P = 0.54). Nine serious adverse events occurred in the polyhexanide group versus 12 in the placebo group; none was attributable to study medication. Emergence of polyhexanide resistance or cross-resistance between polyhexanide and chlorhexidine was not observed. No case of exogenous recolonization by a genotypically different MRSA strain was documented.


CONCLUSIONS
This study suggests that under real-life conditions, a single polyhexanide decolonization course is not effective in eradicating MRSA carriage.
Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland.
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Landelle
Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland.
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von Dach
Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland.
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Haustein
Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland.
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Agostinho
Clinical Microbiology Laboratory, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland.
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Renzi
Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland.
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Renzoni
Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland.
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Pittet
Clinical Microbiology Laboratory, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland.
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Schrenzel
Genomic Research Laboratory, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland.
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François
Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland stephan.harbarth@hcuge.ch.
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Harbarth
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage* / Q000009:adverse effects; D001645:Biguanides / Q000008:administration & dosage* / Q000009:adverse effects; D002353:Carrier State / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D024881:Drug Resistance, Bacterial; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006784:Hospitals, Teaching; D006801:Humans; D008297:Male; D055624:Methicillin-Resistant Staphylococcus aureus / Q000187:drug effects / Q000302:isolation & purification*; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D013203:Staphylococcal Infections / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome; D055815:Young Adult
D000891:Anti-Infective Agents, Local; D001645:Biguanides; D010919:Placebos; C031233:polihexanide