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

Phase 4

Completed

• Conditions: HIV Infections; Staphylococcus Aureus
• Interventions: Drug: Placebo ointment; Drug: Mupirocin calcium ointment, 2%

• Registration Number: NCT00801879
• Lead Sponsor: Columbia University

Brief 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.

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2008-12-03
• Study First Posted: 2008-12-04
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Nasal colonization with Staphylococcus aureus	monthly assessment of colonization (~1 month after each treatment)

Secondary Outcome Measures

Name	Time	Method
Infection with Staphylococcus aureus	monthly

Trial Locations

Locations (2)

Columbia University; 🇺🇸 New York, New York, United States

Project Samaritan Inc.; 🇺🇸 Bronx, New York, United States