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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
47
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%).
The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.
New York University School of Medicine
New York, New York, United States
Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo
Study visit for nasal/peri-rectal swabs
Time frame: 1 Week
Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo
Study visit for nasal/peri-rectal swabs
Time frame: 4 Weeks
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