C Landelle1, E von Dach1, T Haustein1, A Agostinho1, G Renzi2, A Renzoni3, D Pittet1, J Schrenzel2, P François4, S Harbarth5. 1. Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland. 2. Clinical Microbiology Laboratory, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland. 3. Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland. 4. Genomic Research Laboratory, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland. 5. Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle Perret-Gentil 4, 1211 Geneva 14, Switzerland stephan.harbarth@hcuge.ch.
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.
RCT Entities:
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.
Authors: A Renzoni; E Von Dach; C Landelle; S M Diene; C Manzano; R Gonzales; W Abdelhady; C P Randall; E J Bonetti; D Baud; A J O'Neill; A Bayer; A Cherkaoui; J Schrenzel; S Harbarth; P François Journal: Antimicrob Agents Chemother Date: 2017-09-22 Impact factor: 5.191
Authors: Björn Wandhoff; Christin Schröder; Ulrich Nöth; Robert Krause; Burkhard Schmidt; Stephan David; Eike-Eric Scheller; Friedrich Jahn; Michael Behnke; Petra Gastmeier; Tobias Siegfried Kramer Journal: Antimicrob Resist Infect Control Date: 2020-11-30 Impact factor: 4.887