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Completed

NCT Number: NCT03304873

Retapamulin as a Decolonizing Agent for 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.

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Key information

Conditions

MRSA

Age range

9 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retapamulin

Drug

Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%).

Placebo Ointment

Drug

The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.

Primary outcomes

  1. Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo

    Time frame: 1 Week

    Study visit for nasal/peri-rectal swabs

  2. Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo

    Time frame: 4 Weeks

    Study visit for nasal/peri-rectal swabs

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2017
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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