NCT03259269已完成不适用
endTB (Expand New Drugs for TB) Observational Study: Treatment of MDR-TB With Regimens Containing Bedaquiline or Delamanid
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,804
- 试验地点
- 16
- 主要终点
- End of treatment outcome
研究概览
简要总结
This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The information gathered in this study will inform doctors how best to use these TB drugs in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient who receives a treatment regimen containing bedaquiline or delamanid at an endTB site will be invited to participate in this observational study, regardless of age or gender.
- •Any patient who signs the study informed consent form will be included in the study.
排除标准
- •Refusal to participate in the study.
结局指标
主要结局
End of treatment outcome
时间窗: 20 - 24 months of treatment
Final outcomes: cured, treatment completed, treatment failed, lost to follow-up, died, not evaluated
次要结局
未报告次要终点
研究者
研究点 (16)
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