Retapamulin as a Decolonizing Agent for MRSA

MRSA Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304873
• Other study ID #: 17-00907
• Status: Completed
• Phase: Phase 3
• Start date: December 1, 2017
• Est. completion date: March 18, 2019

Study information

• Verified date: March 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 18, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• MRSA

Intervention

Drug:
• Retapamulin
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
The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo	Study visit for nasal/peri-rectal swabs	1 Week
Primary	Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo	Study visit for nasal/peri-rectal swabs	4 Weeks