CTRI/2019/11/021973尚未招募未知
Multi-centre Clinical Trial to Assess the Performance of Culture-free, End-to-end Targeted NGS (tNGS) Solutions for Diagnosis of Drug Resistant TB (DR-TB)
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. A clear TB-positive result by Xpert MTB/RIF OR Xpert MTB/RIF Ultra prior to enrolment, irrespective of RIF-resistance status,
- •2.At risk for drug resistant TB based on at least one of the following risk factors:
- •A.Not responding TB treatment with positive sputum smear or culture after >= 3 months of standard TB treatment.
- •B.Previously diagnosed with Rif-resistant/MDR-TB and failed TB treatment with positive sputum smear or culture after >= 3months of a standard MDR-TB regiment
- •C.Previously received >1 month of treatment for a prior TB episode
- •D.Close contact with a known drug-resistant TB case
- •3.Willing to provide sputum
- •4.Over 18 years of age (or legal adult age corresponding to the site)
- •5.Provision of signed informed consent
排除标准
- •1.Have started treatment for current TB episode more than 7 days prior to date of enrolment (i.e. must have been on treatment for less than 7 days for this TB treatment episode at enrolment)
- •2.Are pregnant or institutionalized or imprisoned
研究者
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