Mupirocin Ointment to Eliminate Nasal Carriage of Staphylococcus Aureus in HIV Infection
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Purpose
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 |
|---|---|---|
|
Nasal Colonization With Staphylococcus Aureus HIV Infections |
Drug: Mupirocin calcium ointment, 2% Drug: Placebo ointment |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intranasal Mupirocin to Eliminate Carriage of Staphylococcus Aureus in HIV Infection |
- Nasal colonization with Staphylococcus aureus [ Time Frame: monthly assessment of colonization (~1 month after each treatment) ] [ Designated as safety issue: No ]
- Infection with Staphylococcus aureus [ Time Frame: monthly ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | September 2003 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Mupirocin ointment
0.25g mupirocin calcium ointment, 2% in each nostril twice daily for 5 days (repeated monthly for up to 8 months)
|
Drug: Mupirocin calcium ointment, 2%
0.25 g in each nostril twice daily for 5 days (given monthly for up to 8 months)
Other Name: Bactroban Nasal 2%
|
|
Placebo Comparator: Placebo ointment
0.25g in each nostril twice daily for 5 days (repeated 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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Dr. Franklin D. Lowy, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00801879 History of Changes |
| Other Study ID Numbers: | AAAB0129, GSK Protocol 187, 1 K08 AI072043-01 |
| Study First Received: | December 3, 2008 |
| Last Updated: | January 7, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Columbia University:
|
mupirocin Staphylococcus aureus colonization infection HIV |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Staphylococcal Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Gram-Positive Bacterial Infections Bacterial Infections Mupirocin Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013