A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Safety and Efficacy of Inhaled Interferon Gamma-1b With Antimycobacterials in Previously Treated or Mod-to-Sev Pulmonary Mycobacterium Avium Complex Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 主要终点
- sustained culture conversion
研究概览
简要总结
The purpose of this research study is to test the safety and effectiveness of inhaled Interferon gamma-1b (IFN-g 1b), when administered for 48 weeks and in combination with oral antibiotics which may be administered for up to 72 weeks for the treatment of a lung infection caused by a bacterium called Mycobacterium avium complex .
FDA has not approved Interferon gamma-1b for use in patients with MAC infection of the lungs, which is the purpose of this study.Interferon gamma-1b and similar proteins play important roles in establishing and maintaining protective immune responses against a variety of microorganisms.
详细描述
Laboratory research has shown that a mouse form of interferon gamma is effective in treating mice with infections caused by bacteria similar to MAC as well as MAC infection.
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
- 否
入选标准
- •Male and female patients, 18 years of age or older, with bacteriologically and radiographically confirmed pulmonary MAC infection who have been treated for their infection for at least 6 months within the previous 2 years, as well as patients with moderate or severe pulmonary disease due to MAC, not previously treated for this infection. Patients with recurrent pulmonary MAC infection after previous successful treatment for pulmonary MAC disease are also eligible.
- •In addition, various laboratory testing must confirm conditions. Patients cannot be positive for HIV or have an extra-pulmonary (in general, outside of the lungs) infection of MAC. Other preconditions related to health or other conditions exist as factors for inclusion or exclusion from this study.
排除标准
- 未提供
结局指标
主要结局
sustained culture conversion
时间窗: 52 weeks
次要结局
未报告次要终点