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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by (Responsible Party):
Franklin D. Lowy, Columbia University
ClinicalTrials.gov Identifier:
NCT00801879
First received: December 3, 2008
Last updated: October 28, 2014
Last verified: October 2014
  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
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

Resource links provided by NLM:


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
Study Completion Date: April 2006
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)

Detailed Description:

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Franklin D. Lowy, Professor of Medicine and Pathology at the New York-Presbyterian Hospital at the Columbia University Medical Center, Columbia University
ClinicalTrials.gov Identifier: NCT00801879     History of Changes
Other Study ID Numbers: AAAB0129, K08AI072043
Study First Received: December 3, 2008
Last Updated: October 28, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014