Retapamulin as a Decolonizing Agent for MRSA

Phase 3

Completed

• Conditions: MRSA
• Interventions: Drug: Placebo Ointment; Drug: Retapamulin

• Registration Number: NCT03304873
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-09
• Study Start: 2017-12-01
• Primary Completion: 2019-02-13
• Study Completion: 2019-03-18
• Results First Submitted: 2020-02-24
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-09
• Last Update Submitted: 2020-03-09
• Results First Posted: 2020-03-19
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Ointment	The placebo used will be a triple purified pharmaceutical grade white petrolatum
Retapamulin	Retapamulin	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo	1 Week	Study visit for nasal/peri-rectal swabs
Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo	4 Weeks	Study visit for nasal/peri-rectal swabs

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States