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

Intranasal Mupirocin to Eliminate Carriage of Staphylococcus Aureus in HIV Infection

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

Study Overview

• Status: Completed
• Conditions: HIV Infections; Staphylococcus Aureus
• Intervention / Treatment: Drug: Mupirocin calcium ointment, 2%; Drug: Placebo ointment

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
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10452
      • Project Samaritan Inc.
    • New York, New York, United States, 10032
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Nasal colonization with Staphylococcus aureus	monthly assessment of colonization (~1 month after each treatment)

Secondary Outcome Measures

Outcome Measure	Time Frame
Infection with Staphylococcus aureus	monthly

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): April 1, 2006
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: December 3, 2008
• First Submitted That Met QC Criteria: December 3, 2008
• First Posted (Estimate): December 4, 2008

Study Record Updates

• Last Update Posted (Estimate): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 28, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: HIV; infection; Staphylococcus aureus; mupirocin; colonization
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; Staphylococcal Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Calcium-Regulating Hormones and Agents; Calcium; Mupirocin
• Other Study ID Numbers: AAAB0129; K08AI072043 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No