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

Information source: Columbia University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Staphylococcus Aureus; HIV Infections

Intervention: Mupirocin calcium ointment, 2% (Drug); Placebo ointment (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Columbia University

Official(s) and/or principal investigator(s):
Rachel J Gordon, MD, MPH, Study Director, Affiliation: Columbia University
Franklin D Lowy, MD, Principal Investigator, Affiliation: Columbia University


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

Clinical Details

Official title: Intranasal Mupirocin to Eliminate Carriage of Staphylococcus Aureus in HIV Infection

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Nasal colonization with Staphylococcus aureus

Secondary outcome: Infection with Staphylococcus aureus

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Project Samaritan Inc., Bronx, New York 10452, United States

Columbia University, New York, New York 10032, United States

Additional Information

Starting date: September 2003
Last updated: October 28, 2014

Page last updated: August 23, 2015

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