Phase 3
N=47
Retapamulin as a Decolonizing Agent for MRSA
MRSA
Bottom Line
View on ClinicalTrials.gov: NCT03304873 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo — 2; 13 Participants — p=0.0004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Retapamulin (Drug); Placebo Ointment (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo |
2; 13 | 0.0004 sig |
| PRIMARY Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo |
12; 9 | 0.99 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03304873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.