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Randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy of polyhexanide for topical decolonization of MRSA carriers

Landelle, C. ; von Dach, E. ; Haustein, T. ; Agostinho, A. ; Renzi, G. ; Renzoni, A. ; Pittet, D. ; Schrenzel, J. ; François, P. ; Harbarth, S.

In: Journal of Antimicrobial Chemotherapy, 2016, vol. 71, no. 2, p. 531-538

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    Title
    • Randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy of polyhexanide for topical decolonization of MRSA carriers
    Author
    • Landelle, C.. Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland
    • von Dach, E.. Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland
    • Haustein, T.. Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland
    • Agostinho, A.. Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland
    • Renzi, G.. Clinical Microbiology Laboratory, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland
    • Renzoni, A.. Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland
    • Pittet, D.. Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland
    • Schrenzel, J.. Clinical Microbiology Laboratory, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland
    • François, P.. Genomic Research Laboratory, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland
    • Harbarth, S.. Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland
    Document Type
    • Postprint
    Language
    • English
    Published in
    • Journal of Antimicrobial Chemotherapy, 2016, vol. 71, no. 2, p. 531-538. Oxford University Press
    Other Version
    OAI-PMH Identifier
    • oai:doc.rero.ch:332397
    Summary
    Abstract Objectives 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.