Clinical trial NCT00801879: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Staphylococcus Aureus
HIV Infections
Keywords: mupirocin
Staphylococcus aureus
colonization
infection
HIV
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2008-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Nasal colonization with Staphylococcus aureus
timeFrame: monthly assessment of colonization (~1 month after each treatment)
Secondary outcomes:
measure: Infection with Staphylococcus aureus
timeFrame: monthly
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Project Samaritan Inc.
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Rachel J Gordon, MD, MPH
role: STUDY_DIRECTOR
affiliation: Columbia University
name: Franklin D Lowy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.