Trials / Completed
CompletedNCT00801879
Mupirocin Ointment to Eliminate Nasal Carriage of Staphylococcus Aureus in HIV Infection
Intranasal Mupirocin to Eliminate Carriage of Staphylococcus Aureus in HIV Infection
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Columbia University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mupirocin calcium ointment, 2% | 0.25 g in each nostril twice daily for 5 days (given 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) |
Timeline
- Start date
- 2003-09-01
- Primary completion
- 2006-04-01
- Completion
- 2006-04-01
- First posted
- 2008-12-04
- Last updated
- 2014-10-29
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00801879. Inclusion in this directory is not an endorsement.