CTRI/2019/07/020139尚未招募2 期
Phase II : Multicentre clinical study to assess the performance of the Xpert MTB/XDR Assay for INH and Second Line Resistance Detection Xpert MTB/XDR Clinical Evaluation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 858
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of Xpert MTB/XDR assay for INH and Second Line resistance detection as a rapid diagnostic modality for XDRTB
研究概览
简要总结
Awaiting approvals from HMSC
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 years and above Symptoms suggesting pulmonary TB Previously received more than 1 month of treatment for prior TB episode Failing TB treatment with positive smear or culture after three months of standard treatment Close contact with drug resistant TB case Newly diagnosed with MDRTB within the last 30 days Previously diagnosed with MDRTB and failed TB treatment with positive sputum or culture after three months of standard MDRTB treatment.
排除标准
- •Participants will be excluded from the study if informed consent is not provided.
结局指标
主要结局
Diagnostic accuracy of Xpert MTB/XDR assay for INH and Second Line resistance detection as a rapid diagnostic modality for XDRTB
时间窗: Diagnostic accuracy of Xpert MTB/XDR assay for INH and Second Line resistance detection as a rapid diagnostic modality for XDRTB at the end of study
次要结局
- Direct performance versus performance on cultured samples(Performance between sites)
研究者
研究点 (2)
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