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Randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy of polyhexanide for topical decolonization of methicillin-resistant Staphylococcus aureus (MRSA) carriers
© Landelle et al; licensee BioMed Central Ltd. 2015
- Published: 16 June 2015
- Risk Difference
- Advisory Board
- Nasal Carrier
Due to increasing resistance, alternatives to mupirocin and chlorhexidine for decolonization of MRSA carriage need to be evaluated.
To evaluate the efficacy of polyhexanide (Prontoderm®) vs placebo in eliminating MRSA carriage at day 28 (D28) after the end of treatment.
In a 1,900-bed teaching hospital, MRSA-colonized patients were randomized into a double-blind, placebo-controlled superiority trial. Patients were treated with either polyhexanide (antiseptic and surface-active substances; group I) or placebo (only surface-active substances; group P) applied to the anterior nares and skin for 10 days. The primary outcome was MRSA decolonization at D28 assessed by both intention-to-treat ([ITT] responder analysis) and per-protocol (PP) analysis (microbiological follow-up ± 7 days and topical treatment ≥ 5 days). Secondary outcomes included MRSA decolonization according to nasal MRSA carriage, safety and emergence of resistance.
Of 2590 patients screened, 146 patients (group I, 71; group P, 75) were randomized between January 2011 and July 2014. Primary outcome was missing for 11 (7.5%) patients. ITT analysis showed that 24/71 (33.8%) patients in group I vs 22/75 (29.3%) in group P 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 vs 17/56 (30.4%) in the placebo arm (risk difference, 5.5%; 95% CI, -12.2% to 23.0%; P=0.54). In the subgroup of MRSA nasal carriers, PP analysis showed that 6/15 (40.0%) patients in group I vs 2/11 (18.2%) in group P were decolonized (P=0.40). Nine serious adverse events occurred in group I vs 12 in group P; none was attributable to study medication. Emergence of polyhexanide resistance was not observed.
This study suggests that under real-life conditions a single polyhexanide decolonization course is marginally effective in eradicating MRSA carriage.
C. Landelle: None declared, E. Von Dach: None declared, T. Haustein: None declared, A. Agostinho: None declared, G. Renzi: None declared, A. Renzoni: None declared, D. Pittet: None declared, J. Schrenzel: None declared, P. François: None declared, S. Harbarth Grant/Research support from: a peer-reviewed research grant funded by Pfizer, Consultant for: the advisory boards of Destiny Pharma, bioMerieux, Novartis, and DaVolterra
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.