Mupirocin Ointment to Eliminate Nasal Carriage of Staphylococcus Aureus in HIV Infection
Primary Purpose
Staphylococcus Aureus, HIV Infections
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mupirocin calcium ointment, 2%
Placebo ointment
Sponsored by
About this trial
This is an interventional treatment trial for Staphylococcus Aureus focused on measuring mupirocin, Staphylococcus aureus, colonization, infection, HIV
Eligibility 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
Sites / Locations
- Project Samaritan Inc.
- Columbia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Mupirocin ointment
Placebo ointment
Arm Description
0.25g mupirocin calcium ointment, 2% in each nostril twice daily for 5 days (repeated monthly for up to 8 months)
0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months)
Outcomes
Primary Outcome Measures
Nasal colonization with Staphylococcus aureus
Secondary Outcome Measures
Infection with Staphylococcus aureus
Full Information
NCT ID
NCT00801879
First Posted
December 3, 2008
Last Updated
October 28, 2014
Sponsor
Columbia University
Collaborators
GlaxoSmithKline, National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00801879
Brief Title
Mupirocin Ointment to Eliminate Nasal Carriage of Staphylococcus Aureus in HIV Infection
Official Title
Intranasal Mupirocin to Eliminate Carriage of Staphylococcus Aureus in HIV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
GlaxoSmithKline, National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus, HIV Infections
Keywords
mupirocin, Staphylococcus aureus, colonization, infection, HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mupirocin ointment
Arm Type
Active Comparator
Arm Description
0.25g mupirocin calcium ointment, 2% in each nostril twice daily for 5 days (repeated monthly for up to 8 months)
Arm Title
Placebo ointment
Arm Type
Placebo Comparator
Arm Description
0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months)
Intervention Type
Drug
Intervention Name(s)
Mupirocin calcium ointment, 2%
Other Intervention Name(s)
Bactroban Nasal 2%
Intervention Description
0.25 g in each nostril twice daily for 5 days (given monthly for up to 8 months)
Intervention Type
Drug
Intervention Name(s)
Placebo ointment
Intervention Description
Placebo ointment 0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months)
Primary Outcome Measure Information:
Title
Nasal colonization with Staphylococcus aureus
Time Frame
monthly assessment of colonization (~1 month after each treatment)
Secondary Outcome Measure Information:
Title
Infection with Staphylococcus aureus
Time Frame
monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel J Gordon, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Franklin D Lowy, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Project Samaritan Inc.
City
Bronx
State/Province
New York
ZIP/Postal Code
10452
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20686410
Citation
Gordon RJ, Chez N, Jia H, Zeller B, Sobieszczyk M, Brennan C, Hisert KB, Lee MH, Vavagiakis P, Lowy FD. The NOSE study (nasal ointment for Staphylococcus aureus eradication): a randomized controlled trial of monthly mupirocin in HIV-infected individuals. J Acquir Immune Defic Syndr. 2010 Dec;55(4):466-72. doi: 10.1097/QAI.0b013e3181ec2a68.
Results Reference
result
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Mupirocin Ointment to Eliminate Nasal Carriage of Staphylococcus Aureus in HIV Infection
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