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

HIV Infections Clinical Trial

Official title:

Intranasal Mupirocin to Eliminate Carriage of Staphylococcus Aureus in HIV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801879
• Other study ID #: AAAB0129
• Secondary ID: K08AI072043
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2008
• Last updated: October 28, 2014
• Start date: September 2003
• Est. completion date: April 2006

Study information

• Verified date: October 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection
• Staphylococcus Aureus

Intervention

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 ointment 0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months)

Locations

Country	Name	City	State
United States	Project Samaritan Inc.	Bronx	New York
United States	Columbia University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	GlaxoSmithKline, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal colonization with Staphylococcus aureus		monthly assessment of colonization (~1 month after each treatment)	No
Secondary	Infection with Staphylococcus aureus		monthly	No