Retapamulin for Reducing MRSA Nasal Carriage

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Irvine
• Collaborator: Agency for Healthcare Research and Quality (AHRQ)
• Treatments: Retapamulin

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