Retapamulin for Reducing MRSA Nasal Carriage

NCT01461668 | Completed Phase 4 Results DMC

• 1 other identifier: OCRT10049
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a randomized placebo-controlled double-blinded study of nasal decolonization with retapamulin vs. placebo for the eradication of MRSA nasal carriage among adult carriers with low-level (MIC 8-256) and high-level mupirocin resistant (MIC \>256) strains. Objectives:

1. 1.To determine the percent of intervention vs. control patients with successful MRSA nasal decolonization as determined by bilateral nares swabs following a 5-day twice-a-day regimen of retapamulin.
2. 2.To determine the time to decolonization based upon interim and final bilateral nares swabs.
3. 3.To determine the acceptability of retapamulin by surveying participants about their experience and adverse events experienced during this study.

Conditions

Methicillin-Resistant Staphylococcus Aureus

Keywords

MRSA; MRSA resistant to mupirocin

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With MRSA Clearance

  Proportion of participants with MRSA clearance at the end of the follow up period

  47 days

Study Arms (2)

Retapamulin

EXPERIMENTAL

Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of retapamulin with follow up bilateral nares swab one week following completion of therapy (\~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (retapamulin) to begin one week following swab collection (\~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (\~D47).

Drug: Retapamulin

Placebo

PLACEBO COMPARATOR

Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of a placebo with follow up bilateral nares swab one week following completion of therapy (\~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (placebo) to begin one week following swab collection (\~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (\~D47).

Drug: Placebo

Interventions

Retapamulin DRUG

Two times a day for 5 days

Also known as: Altabax

Retapamulin

Placebo DRUG

Two times a day for 5 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Have a type of MRSA that is resistant to mupirocin (a drug used to treat MRSA)

You may not qualify if:

• Allergic to retapamulin
• Unable to use retapamulin via your nose (i.e. nose surgery, etc.)
• Are pregnant and/or breastfeeding

Sponsors & Collaborators

• University of California, Irvine: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of California, Irivne

Irvine, California, 92617, United States

Location

MeSH Terms

Interventions

retapamulin

Limitations and Caveats

Recruitment challenges from low yield of mupirocin-resistant MRSA. Trial suspended when funding concluded. Extensive efforts to acquire new sites and new funding to extend trial requirement were unsuccessful. Trial was closed and analysis completed.

Results Point of Contact

• Title: Raveena Singh
• Organization: University of California Irvine

ravsingh@uci.edu

949-824-9285

Study Officials

• Susan Huang, MD, MPH

  University of California, Irivne - School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Epidemiology and Infection Prevention

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: October 28, 2011
• Study Start: July 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 2, 2018
• Results First Posted: April 2, 2018

Record last verified: 2018-03

Locations

US (1)