Retapamulin as a Decolonizing Agent for MRSA

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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MRSA

Intervention / Treatment
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* Drug: Retapamulin
* Drug: Placebo Ointment


Participation Criteria
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Eligibility Criteria
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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. Nasal and/or rectal culture positive for mupirocin-resistant methicillin-resistant Staphylococcus aureus (MRSA) Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Pregnant or lactating Unable to appropriately consent Open sores in either of the study sites (nares or rectum) Recent surgical procedure to either study site (nares or rectum) Concurrent use of Rifampin or Trimethoprim/Sulfamethoxazole Current active MRSA infection Immunocompromised Presence of endotracheal tube, tracheostomy tube or other foreign body in upper airway

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retapamulin<br>Thin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days. | Drug: Retapamulin<br>* 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%).<br>|
| Placebo Comparator: Placebo<br>The placebo used will be a triple purified pharmaceutical grade white petrolatum | Drug: Placebo Ointment<br>* The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo | Study visit for nasal/peri-rectal swabs | 1 Week | 
| Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo | Study visit for nasal/peri-rectal swabs | 4 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal MRSA, mupirocin-resistant nasal MRSA