CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 53 enrolled
Drug / intervention
Retapamulin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01461668
NCT01461668Phase 4Completed

Retapamulin for Reducing MRSA Nasal Carriage

University of California, Irvine·interventional·Posted Oct 28, 2011·Updated Apr 2, 2018

In Brief

A Phase 4 clinical trial evaluating Retapamulin and Placebo for Methicillin-Resistant Staphylococcus Aureus. Completed, enrolled 53 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 28, 2011
Enrollment StartJul 1, 2012
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 14.7 years ago

Interventions

Retapamulindrug

Two times a day for 5 days

Placebodrug

Two times a day for 5 days