Trial record 10 of 18 for:    " December 03, 2008":" January 02, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00801879
Recruitment Status : Completed
First Posted : December 4, 2008
Last Update Posted : October 29, 2014
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Franklin D. Lowy, Columbia University

Brief Summary:

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 or disease Intervention/treatment Phase
Staphylococcus Aureus HIV Infections Drug: Mupirocin calcium ointment, 2% Drug: Placebo ointment Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Mupirocin to Eliminate Carriage of Staphylococcus Aureus in HIV Infection
Study Start Date : September 2003
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Nasal colonization with Staphylococcus aureus [ Time Frame: monthly assessment of colonization (~1 month after each treatment) ]

Secondary Outcome Measures :
  1. Infection with Staphylococcus aureus [ Time Frame: monthly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00801879

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
National Institute of Allergy and Infectious Diseases (NIAID)
Study Director: Rachel J Gordon, MD, MPH Columbia University
Principal Investigator: Franklin D Lowy, MD Columbia University

Publications of Results:
Responsible Party: Franklin D. Lowy, Professor of Medicine and Pathology at the New York-Presbyterian Hospital at the Columbia University Medical Center, Columbia University Identifier: NCT00801879     History of Changes
Other Study ID Numbers: AAAB0129
K08AI072043 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2008    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014

Keywords provided by Franklin D. Lowy, Columbia University:
Staphylococcus aureus

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Communicable Diseases
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
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action