Safety of Rifampicin at High Dose for the Treatment of Adult Subjects With Complex Drug Susceptible Pulmonary and Extrapulmonary Tuberculosis
试验速览
- 阶段
- 2 期
- 入组人数
- 130
- 试验地点
- 5
- 主要终点
- Safety of rifampicin at 35mg/kg/day
研究概览
简要总结
The purpose of this study is to assess the safety of rifampicin given at a dose three times as the standard one, in persons with tuberculosis that belong to groups that have not been widely included in previous trials.
详细描述
A prospective, one-arm, open-label trial to evaluate the safety of rifampicin at 35mg/kg per day, added to the remaining standard first-line drugs, in subjects with tuberculosis belonging to groups that have been underrepresented in previous trials: persons living with HIV, older than 65 years, malnourished, diabetics, and chronic stable liver disease. The main outcome is the rate of severe adverse events and adverse events leading to treatment modification as compared to that in a historical cohort (patietns belonging to these groups treated in the same centers from 2017-2019). Microbiological efficacy and extended follow-up data until one year after treatment will also be collected.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
R35HZE
Participants treated with rifampicin at a dose of 35 mg per kilogram of body weight per day, added to the standard doses of isoniazid, pyrazinamide and ethambutol.
干预措施: Rifampin (Drug)
结局指标
主要结局
Safety of rifampicin at 35mg/kg/day
时间窗: During the first 8 weeks after treatment start
Rate of grade 3 or higher adverse events as compared to that in historical controls
次要结局
- Tolerability of rifampicin at 35mg/kg/day(During the first 8 weeks after treatment start)
- Efficacy of rifampicin at 35mg/kg/day in pulmonary tuberculosis(At week 8 after treatment start)