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Sponsors and Collaborators: |
Columbia University GlaxoSmithKline National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00801879 |
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
Condition | Intervention | Phase |
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Nasal Colonization With Staphylococcus Aureus HIV Infections |
Drug: Mupirocin calcium ointment, 2% Drug: Placebo ointment |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Intranasal Mupirocin to Eliminate Carriage of Staphylococcus Aureus in HIV Infection |
Enrollment: | 100 |
Study Start Date: | September 2003 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Mupirocin ointment: Active Comparator
0.25g mupirocin calcium ointment, 2% in each nostril twice daily for 5 days (repeated monthly for up to 8 months)
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Drug: Mupirocin calcium ointment, 2%
0.25 g in each nostril twice daily for 5 days (given monthly for up to 8 months)
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Placebo ointment: Placebo Comparator
0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months)
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Drug: Placebo ointment
Placebo ointment 0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Project Samaritan Inc. | |
Bronx, New York, United States, 10452 | |
Columbia University | |
New York, New York, United States, 10032 |
Study Director: | Rachel J Gordon, MD, MPH | Columbia University |
Principal Investigator: | Franklin D Lowy, MD | Columbia University |
Responsible Party: | Columbia University ( Dr. Franklin D. Lowy ) |
Study ID Numbers: | AAAB0129, GSK Protocol 187, 1 K08 AI072043-01 |
Study First Received: | December 3, 2008 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00801879 |
Health Authority: | United States: Institutional Review Board |
mupirocin Staphylococcus aureus colonization infection HIV |
Bacterial Infections Virus Diseases Calcium, Dietary Staphylococcal Infections Gram-Positive Bacterial Infections Sexually Transmitted Diseases, Viral |
Mupirocin HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Pharmacologic Actions Protein Synthesis Inhibitors Anti-Bacterial Agents Therapeutic Uses Lentivirus Infections |