drugset / Trial / NCT03304873

Retapamulin as a Decolonizing Agent for MRSA

NCT03304873

Phase 3 Completed 47 enrolled NYU Langone Health
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to investigate the efficacy of retapamulin to reduce carriage of MRSA via a randomized, double-blind, placebo-controlled clinical study testing retapamulin among patients with confirmed mupirocin-resistant nasal and/or rectal MRSA colonization. The sample size will include 27 subjects in each of the two arms of the study (retapamulin versus placebo) for a total of 54 subjects. Participants who are found to be nasal and/or rectal colonized with MRSA will be randomized to receive either retapamulin or placebo applied nasally and rectally for a total of 5 days. Nasal and rectal swabs will be collected at pre-defined time points during study duration (screening swab, swab one week after completion of topical therapy, swab 4 weeks after completion of topical therapy) to assess MRSA colonization status. The colonization rates of both groups will be assessed via Fisher's Exact Test.

Timeline

Start
2017-12-01
Primary completion
2019-02-13
Completion
2019-03-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Retapamulin Small molecule 1 % Topical