Overview

Retapamulin as a Decolonizing Agent for MRSA

Status:
Completed
Trial end date:
2019-03-18
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York University School of Medicine
NYU Langone Health
Treatments:
Mupirocin
Petrolatum
Retapamulin
Criteria
Inclusion Criteria:

1. 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.

2. Ages 9 months to 17 years

3. Residing in the zip codes which reflect Orthodox Jewish neighborhoods where there is a
current outbreak of this strain of MRSA.

4. 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:

1. Pregnant or lactating

2. Unable to appropriately consent

3. Open sores in either of the study sites (nares or rectum)

4. Recent surgical procedure to either study site (nares or rectum)

5. Concurrent use of Rifampin or Trimethoprim/Sulfamethoxazole

6. Current active MRSA infection

7. Immunocompromised

8. Presence of endotracheal tube, tracheostomy tube or other foreign body in upper airway