Retapamulin for Reducing MRSA Nasal Carriage

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of California, Irvine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susan Huang, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01461668
First received: October 26, 2011
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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. 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. To determine the time to decolonization based upon interim and final bilateral nares swabs.
  3. To determine the acceptability of retapamulin by surveying participants about their experience and adverse events experienced during this study.

The duration of participant follow-up is expected to last up to 7 weeks.

This study will evaluate the safety and effectiveness of Altabax (retapmulin) during decolonization of MRSA carriers with mupirocin-resistant strains, stratified by low-level and high-level resistance to mupirocin. Mupirocin resistance is increasingly common and there is no approved substitute topical agent for decolonization of the MRSA nasal reservoir.


Condition Intervention Phase
Methicillin-Resistant Staphylococcus Aureus
Drug: Retapamulin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Retapamulin for Reducing MRSA Nasal Carriage

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Time to MRSA clearance [ Time Frame: 47 days ] [ Designated as safety issue: No ]
    Successful nares decolonization at the end of the follow up period


Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Retapamulin
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
Two times a day for 5 days
Other Name: Altabax
Placebo Comparator: Placebo
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
Two times a day for 5 days
Other Name: Placebo

Detailed Description:

This study will evaluate the utility of retapamulin, a topical ointment FDA approved for skin infection, as a novel agent for MRSA decolonization and prevention of healthcare-associated MRSA infection. Retapamulin is a first-in-class semi-synthetic pleuromutilin antibiotic that inhibits protein synthesis by interacting with the bacterial ribosome 50S subunit. It received FDA approval in 2007 for the topical treatment of impetigo in adults and pediatric patients.

We propose to evaluate retapamulin as an investigational agent for the nasal decolonization of MRSA carriers whose strains demonstrate low-level and high-level resistance to mupirocin. Mupirocin resistance is increasingly common and there is no approved substitute topical agent for decolonization of the MRSA nasal reservoir.

We 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. Randomization will be stratified by low vs high level resistance.

Consenting adult (at least 18 years old) subjects will be randomized to 1% retapamulin or placebo ointment intra-nasally twice a day for 5 days (D1-5) 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 or 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).

Consenting adult (at least 18 years old)subjects will be given retapamulin or placebo. At the time of recruitment, all subjects will complete a detailed survey administered by trained research staff. This survey will include questions related to self care, home hygiene practices, and known risk factors for MRSA acquisition. Subject follow up will include repeat bilateral nares swabs and follow up surveys related to compliance, experience (side effects/concerns) with the assigned regimen, and ongoing risk factors will occur either during a home visit (or facility visit if the patient is admitted to a hospital or nursing home at the time of the required visit) or at the University of California Irvine (UCI) Institute for Clinical and Translational Science (ICTS), a Clinical and Translational Science Award (CTSA) site which provides clinic visit support for pilot studies.

Outcomes will include successful nares decolonization at the end of the follow up period (D47). We will detail the sequence of clearance or re-colonization based upon the two follow up nares swabs, as well as any adverse events, which are expected to be related to local irritation in a small percent of subjects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergic to retapamulin
  • Unable to use retapamulin via your nose (i.e. nose surgery, etc.)
  • Are pregnant and/or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461668

Contacts
Contact: Raveena Singh, MA 714-456-2266 ravsingh@uci.edu

Locations
United States, California
University of California, Irivne Recruiting
Irvine, California, United States, 92617
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Susan Huang, MD, MPH University of California, Irivne - School of Medicine
  More Information

No publications provided

Responsible Party: Susan Huang, Director of Epidemiology and Infection Prevention, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01461668     History of Changes
Other Study ID Numbers: OCRT10049
Study First Received: October 26, 2011
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
MRSA
MRSA resistant to mupirocin

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014