Retapamulin as a Decolonizing Agent for MRSA
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 12/12/2018 |
| Start Date: | December 1, 2017 |
| End Date: | February 2020 |
| Contact: | Ami Patel, MD, MPH |
| Email: | Ami.Patel@nyumc.org |
| Phone: | 212 263 5454 |
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)
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.
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.
Inclusion Criteria:
- Admission to the general pediatric floor and pediatric intensive care units at NYU
Langone Medical Center
- 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:
- 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
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Jennifer Lighter, MD
Phone: 212-263-5454
New York University School of Medicine NYU School of Medicine has a proud history that...
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