Retapamulin as a Decolonizing Agent for MRSA

Completed · Phase 3 · Has a placebo group

Conditions studied: MRSA

In brief

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.

Key facts

Study ID

NCT03304873

Run by

NYU Langone Health

People needed

47

Starts

2017-12-01

Expected to finish

2019-03-18

Last updated by the study team

2020-03-19

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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