Retapamulin as a Decolonizing Agent for MRSA

NCT03304873 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 17-00907
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

MRSA

Keywords

rectal MRSA; mupirocin-resistant nasal MRSA

Outcome Measures

Primary Outcomes (2)

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

  Study visit for nasal/peri-rectal swabs

  1 Week

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

  Study visit for nasal/peri-rectal swabs

  4 Weeks

Study Arms (2)

Retapamulin

EXPERIMENTAL

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.

Drug: Retapamulin

Placebo

PLACEBO COMPARATOR

The placebo used will be a triple purified pharmaceutical grade white petrolatum

Drug: Placebo Ointment

Interventions

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%).

Retapamulin

Placebo Ointment DRUG

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

Placebo

Eligibility Criteria

• Age: 9 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

retapamulin

Results Point of Contact

• Title: Jennifer Lighter, MD
• Organization: NYU Grossman School of Medicine

Jennifer.Lighter@nyulangone.org

212-263-5454

Study Officials

• Jennifer Lighter, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 9, 2017
• Study Start: December 1, 2017
• Primary Completion: February 13, 2019
• Study Completion: March 18, 2019
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-03

Locations

US (1)