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Mupirocin Ointment to Eliminate Nasal Carriage of Staphylococcus Aureus in HIV Infection
This study has been completed.
Sponsors and Collaborators: Columbia University
GlaxoSmithKline
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: Columbia University
ClinicalTrials.gov Identifier: NCT00801879
  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 IV

MedlinePlus related topics: AIDS
Drug Information available for: Calcium gluconate Mupirocin Mupirocin calcium
U.S. FDA Resources
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

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Nasal colonization with Staphylococcus aureus [ Time Frame: monthly assessment of colonization (~1 month after each treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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)
Drug: Mupirocin calcium ointment, 2%
0.25 g in each nostril twice daily for 5 days (given monthly for up to 8 months)
Placebo ointment: Placebo Comparator
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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801879

Locations
United States, New York
Project Samaritan Inc.
Bronx, New York, United States, 10452
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
GlaxoSmithKline
Investigators
Study Director: Rachel J Gordon, MD, MPH Columbia University
Principal Investigator: Franklin D Lowy, MD Columbia University
  More Information

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

Keywords provided by Columbia University:
mupirocin
Staphylococcus aureus
colonization
infection
HIV

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009