Randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy of polyhexanide for topical decolonization of methicillin-resistant Staphylococcus aureus (MRSA) carriers

Abstract

Introduction: Due to increasing resistance, alternatives to mupirocin and chlorhexidine for decolonization of MRSA carriage need to be evaluated. Objectives: To evaluate the efficacy of polyhexanide (Prontoderm®) vs placebo in eliminating MRSA carriage at day 28 (D28) after the end of treatment. Methods: 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. Results: 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. Conclusion: This study suggests that under real‐life conditions a single polyhexanide decolonization course is marginally effective in eradicating MRSA carriage.