Clinical Efficacy of Rifabutin in the Treatment of Serious and Life Threatening Infections Due to Mycobacterium Avium Complex, or Drug Resistant Mycobacterium Tuberculosis, or Other Drug Resistant Mycobacterium
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures)
研究概览
简要总结
Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections who have failed or are intolerant of rifampin.
Rifabutin may be a reasonable alternative agent in patients who fail rifampin or or intolerant of rifampin.
详细描述
Rifabutin dosage 150-300 mg daily( depending upon age, and clinical conditions) in NTM patients who fail treatment with rifampin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18 and older with positive acid-fast bacilli smears and cultures for drug-resistant mycobacteria
排除标准
- •Children less than 18 years of age
- •Pregnancy
- •Low platelet count, except with very serious disease
研究组 & 干预措施
Rifabutin
Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections or other NTM disease who fail therapy with other drugs ( i.e., rifampin)
干预措施: Rifabutin (Drug)
结局指标
主要结局
Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures)
时间窗: 6 mos
neg cultures X3( sputum conversion)
次要结局
- Microbiological Cultures(1year)
研究者
Richard J. Wallace, Jr., M.D.
Chairman Department of Microbiology
The University of Texas Health Science Center at Tyler