NCT03304873

Retapamulin as a Decolonizing Agent for MRSA

A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Retapamulin as a Topical Decolonizing Agent for Mupirocin Resistant Methicillin Resistant Staphylococcus Aureus (MRSA)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 9 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• MRSA

Interventions

Type	Name	Description
DRUG	Retapamulin	Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%).
DRUG	Placebo Ointment	The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-02-13
• Completion: 2019-03-18
• First posted: 2017-10-09
• Last updated: 2020-03-19
• Results posted: 2020-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study