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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-04-30

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

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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.

Conditions

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Staphylococcus Aureus HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mupirocin ointment

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

Group Type ACTIVE_COMPARATOR

Mupirocin calcium ointment, 2%

Intervention Type DRUG

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

Placebo ointment

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

Group Type PLACEBO_COMPARATOR

Placebo ointment

Intervention Type DRUG

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

Interventions

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Mupirocin calcium ointment, 2%

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

Intervention Type DRUG

Placebo ointment

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

Intervention Type DRUG

Other Intervention Names

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Bactroban Nasal 2%

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes