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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Staphylococcus Aureus, HIV Infections

Intervention / Treatment
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* Drug: Mupirocin calcium ointment, 2%
* Drug: Placebo ointment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mupirocin ointment<br>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%<br>* 0.25 g in each nostril twice daily for 5 days (given monthly for up to 8 months)<br>* Other names: Bactroban Nasal 2%;|
| Placebo Comparator: Placebo ointment<br>0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months) | Drug: Placebo ointment<br>* Placebo ointment 0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal colonization with Staphylococcus aureus |  | monthly assessment of colonization ( 1 month after each treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection with Staphylococcus aureus |  | monthly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mupirocin, Staphylococcus aureus, colonization, infection, HIV