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Mupirocin Ointment to Eliminate Nasal Carriage of Staphylococcus Aureus in HIV Infection

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT00801879
Collaborator
GlaxoSmithKline (Industry), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
100
Enrollment
2
Locations
2
Arms
31
Duration (Months)
50
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Staphylococcus aureus is a bacteria that causes serious, often life threatening infections including pneumonia, wound, and bloodstream infections. Persons with AIDS are at high risk for S. aureus infections. They are also at high risk for nasal carriage of S. aureus. In fact, nasal carriage is a known risk factor for subsequent S. aureus infection. Topical mupirocin, an antibiotic when applied to the anterior nares, is a safe, effective way to eliminate S. aureus colonization. Some studies have shown that mupirocin can also decrease the risk of S. aureus infection, but many of those studies utilized historical controls and none were rigorously tested among AIDS patients over an extended period of time.

The main purpose of this randomized, double-blinded, placebo controlled study is to determine if mupirocin can eliminate S. aureus nasal colonization in residents at PSI (inpatient, drug rehabilitation facility for AIDS patients in the Bronx.) PSI residents currently have a high incidence of S. aureus nasal colonization and infection. Nasal cultures followed by twice daily application of mupirocin vs. placebo for five days will be performed on a monthly basis for 8 months. the study will examine whether mupirocin decreases the incidence of S. aureus infections and prevents S. aureus nasal colonization. The study is important because it may show that mupirocin is an effective way to eliminate nasal colonization and prevent S. aureus infections in AIDS patients, among those at highest risk for serious S. aureus infection.

Hypothesis: Monthly application of mupirocin will reduce nasal colonization with S.aureus

Condition or Disease Intervention/Treatment Phase
  • Drug: Mupirocin calcium ointment, 2%
  • Drug: Placebo ointment
 Phase 4

Detailed Description

This was a randomized double-blinded placebo controlled trial. Subjects were treated with intranasal mupirocin or placebo on a monthly basis and tested for nasal colonization a month after each treatment. This was performed up to 8 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Intranasal Mupirocin to Eliminate Carriage of Staphylococcus Aureus in HIV Infection
Study Start Date :
Sep 1, 2003
Actual Primary Completion Date :
Apr 1, 2006
Actual Study Completion Date :
Apr 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Mupirocin ointment

0.25g mupirocin calcium ointment, 2% in each nostril twice daily for 5 days (repeated monthly for up to 8 months)

Drug: Mupirocin calcium ointment, 2%
0.25 g in each nostril twice daily for 5 days (given monthly for up to 8 months)
Other Names:
  • Bactroban Nasal 2%

    		•
    Placebo Comparator: Placebo ointment

    0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months)

    Drug: Placebo ointment
    Placebo ointment 0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months)

    Outcome Measures

    Primary Outcome Measures

    1. Nasal colonization with Staphylococcus aureus [monthly assessment of colonization (~1 month after each treatment)]

    Secondary Outcome Measures

    1. Infection with Staphylococcus aureus [monthly]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Resident at Project Samaritan Inc. (PSI)
    Exclusion Criteria:

    • Past hypersensitivity to mupirocin or glycerol

    • Pregnancy

    • Lactation

    • Expected discharge from PSI in the following month

    • Treatment with intranasal mupirocin within the preceding two months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Project Samaritan Inc. Bronx New York United States 10452
    2 Columbia University New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University
    • GlaxoSmithKline
    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Study Director: Rachel J Gordon, MD, MPH, Columbia University
    • Principal Investigator: Franklin D Lowy, MD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Franklin D. Lowy, Professor of Medicine and Pathology at the New York-Presbyterian Hospital at the Columbia University Medical Center, Columbia University
    ClinicalTrials.gov Identifier:
    NCT00801879
    Other Study ID Numbers:
    • AAAB0129
    • K08AI072043
    First Posted:
    Dec 4, 2008
    Last Update Posted:
    Oct 29, 2014
    Last Verified:
    Oct 1, 2014
    Keywords provided by Franklin D. Lowy, Professor of Medicine and Pathology at the New York-Presbyterian Hospital at the Columbia University Medical Center, Columbia University
    mupirocin
    Staphylococcus aureus
    colonization
    infection
    HIV
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    HIV Infections
    Acquired Immunodeficiency Syndrome
    Staphylococcal Infections
    Mupirocin
    Calcium

    Study Results

    No Results Posted as of Oct 29, 2014