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