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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00801879
Enrollment
100
Registered
2008-12-04
Start date
2003-09-30
Completion date
2006-04-30
Last updated
2014-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Staphylococcus Aureus, HIV Infections

Keywords

mupirocin, Staphylococcus aureus, colonization, infection, HIV

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.

Interventions

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)

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Nasal colonization with Staphylococcus aureusmonthly assessment of colonization (~1 month after each treatment)

Secondary

MeasureTime frame
Infection with Staphylococcus aureusmonthly

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026