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Completed

NCT Number: NCT00801879

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mupirocin calcium ointment, 2%

Drug

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

Other names: Bactroban Nasal 2%

Placebo Ointment

Drug

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

Primary outcomes

  1. Nasal colonization with Staphylococcus aureus

    Time frame: monthly assessment of colonization (~1 month after each treatment)

Secondary outcomes

  1. Infection with Staphylococcus aureus

    Time frame: monthly

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • GlaxoSmithKline
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Intranasal Mupirocin to Eliminate Carriage of Staphylococcus Aureus in HIV Infection

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Dec 4, 2008
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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