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

NCT00801879 | Completed Phase 4

• 2 other identifiers: AAAB0129K08AI072043
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Conditions

Staphylococcus Aureus; HIV Infections

Keywords

mupirocin; Staphylococcus aureus; colonization; infection; HIV

Outcome Measures

Primary Outcomes (1)

• Nasal colonization with Staphylococcus aureus

  monthly assessment of colonization (~1 month after each treatment)

Secondary Outcomes (1)

• Infection with Staphylococcus aureus

  monthly

Study Arms (2)

Mupirocin ointment

ACTIVE COMPARATOR

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%

Placebo ointment

PLACEBO COMPARATOR

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

Drug: Placebo ointment

Interventions

Mupirocin calcium ointment, 2% DRUG

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

Also known as: Bactroban Nasal 2%

Mupirocin ointment

Placebo ointment DRUG

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

Placebo ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident at Project Samaritan Inc. (PSI)

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• GlaxoSmithKline: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Columbia University

New York, New York, 10032, United States

Location

Project Samaritan Inc.

The Bronx, New York, 10452, United States

Location

Related 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. J Acquir Immune Defic Syndr. 2010 Dec;55(4):466-72. doi: 10.1097/QAI.0b013e3181ec2a68.

  PMID: 20686410 RESULT

MeSH Terms

Conditions

Staphylococcal Infections; HIV Infections; Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Rachel J Gordon, MD, MPH

  Columbia University

  STUDY DIRECTOR

• Franklin D Lowy, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pathology at the New York-Presbyterian Hospital at the Columbia University Medical Center

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: December 4, 2008
• Study Start: September 1, 2003
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

US (2)