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临床试验/NCT00801879
NCT00801879已完成4 期

Intranasal Mupirocin to Eliminate Carriage of Staphylococcus Aureus in HIV Infection

Columbia University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2003年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
2
主要终点
Nasal colonization with Staphylococcus aureus

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Resident at Project Samaritan Inc. (PSI)

排除标准

  • 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

研究组 & 干预措施

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)

干预措施: Mupirocin calcium ointment, 2% (Drug)

Placebo ointment

Placebo Comparator

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

干预措施: Placebo ointment (Drug)

结局指标

主要结局

Nasal colonization with Staphylococcus aureus

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

次要结局

  • Infection with Staphylococcus aureus(monthly)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Franklin D. Lowy

Professor of Medicine and Pathology at the New York-Presbyterian Hospital at the Columbia University Medical Center

Columbia University

研究点 (2)

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