Retapamulin as a Decolonizing Agent for MRSA (NCT03304873) | Clinical Trial Compass
CompletedPhase 3
Retapamulin as a Decolonizing Agent for MRSA
United States47 participantsStarted 2017-12-01
Plain-language 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.
Who can participate
Age range9 Months – 17 Years
SexALL
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Inclusion criteria
✓. Admission to the general pediatric floor and pediatric intensive care units at NYU Langone Medical Center or visit to study team members at ODA clinic (Park Ave locations) in Williamsburg Brooklyn.
✓. Ages 9 months to 17 years
✓. Residing in the zip codes which reflect Orthodox Jewish neighborhoods where there is a current outbreak of this strain of MRSA.