Phase 4 N=53 Randomized Quadruple-blind Prevention

Retapamulin for Reducing MRSA Nasal Carriage

Methicillin-Resistant Staphylococcus Aureus

Bottom Line

View on ClinicalTrials.gov: NCT01461668 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2018

Primary outcome: Primary: Proportion of Participants With MRSA Clearance — 8; 4 Participants — p=0.320

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Retapamulin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, Irvine
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Participants With MRSA Clearance	8; 4	0.320

Summary

The investigators will conduct a randomized placebo-controlled double-blinded study of nasal decolonization with retapamulin vs. placebo for the eradication of MRSA nasal carriage among adult carriers with low-level (MIC 8-256) and high-level mupirocin resistant (MIC >256) strains. Objectives: 1. To determine the percent of intervention vs. control patients with successful MRSA nasal decolonization as determined by bilateral nares swabs following a 5-day twice-a-day regimen of retapamulin. 2. To determine the time to decolonization based upon interim and final bilateral nares swabs. 3. To determine the acceptability of retapamulin by surveying participants about their experience and adverse events experienced during this study. The duration of participant follow-up is expected to last up to 7 weeks. This study will evaluate the safety and effectiveness of Altabax (retapamulin) during decolonization of MRSA carriers with mupirocin-resistant strains, stratified by low-level and high-level resistance to mupirocin. Mupirocin resistance is increasingly common and there is no approved substitute topical agent for decolonization of the MRSA nasal reservoir.

Eligibility Criteria

Inclusion Criteria

18 years of age or older
Have a type of MRSA that is resistant to mupirocin (a drug used to treat MRSA)

Exclusion Criteria

Allergic to retapamulin
Unable to use retapamulin via your nose (i.e. nose surgery, etc.)
Are pregnant and/or breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01461668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.