Targeted Sequencing to Enhance, Liberate, and Optimize Treatment of Drug-resistant Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Number of participants with prespecified end of treatment outcomes
研究概览
简要总结
TS ELiOT is a stepped-wedge, cluster randomized trial assessing the effect of a next-generation sequencing-based strategy on rifampin-resistant tuberculosis management and patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active RR-TB diagnosed at a study facility during the study period
- •Positive Mtb culture, smear, or specimen derivative (e.g., GenoLyse remnant, Xpert cartridge extract)
排除标准
- •Patient expects to relocate/move residence outside of the study region
- •Patient does not agree to participate in the study
- •In addition, participants later found to have isolates with rifamycin susceptibility on at least two additional tests (e.g., phenotypic DST, LPA, or sequencing) will be considered late exclusions.
研究组 & 干预措施
Sequencing Intervention in addition to standard of care
Batched targeted deep sequencing in addition to the locally accepted standard of care drug susceptibility determination of multidrug/extensively drug-resistant tuberculosis (M/XDR-TB)
干预措施: Targeted next-generation sequencing (Diagnostic Test)
Standard of Care
Locally accepted standard of care which is consistent with the WHO recommendations for the drug susceptibility determination of M/XDR-TB
结局指标
主要结局
Number of participants with prespecified end of treatment outcomes
时间窗: At the anticipated completion of prescribed treatment, up to 18 months
The number of participants with each of the following prespecified end of treatment outcomes will be reported: cure, treatment completed, loss to follow up, treatment failure, death, transfer, and still on treatment.
次要结局
- Number of participants with acquired drug resistance(At the anticipated completion of prescribed treatment, up to 18 months)
- 12-month relapse-free survival(From completion of prescribed treatment to death or TB recurrence, up to 12 months)
- Time to effective treatment initiation with three drugs(From diagnosis to treatment initiation with at least three effective drugs, up to 18 months)
- Time to effective treatment initiation with four drugs(From diagnosis to treatment initiation with at least four effective drugs, up to 18 months)
- Exposure time to ineffective drugs(At the anticipated completion of prescribed treatment, up to 18 months)
- Time to culture conversion(From diagnosis to stable culture conversion, up to 9 months)