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

NCT00801879 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-10-29

No results posted yet for this study

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

Conditions

  • Staphylococcus Aureus
  • HIV Infections

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Rachel J Gordon, MD, MPH · Columbia University

  • Franklin D Lowy, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2006-04-30
Completion
2006-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00801879 on ClinicalTrials.gov