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
- 不适用
- 状态
- 尚未招募
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Point estimates, with 95% confidence intervals, of sensitivity and specificity for rifampicin, isoniazid, fluoroquinolones, second-line injectables, and pyrazinamide resistance detection for up to 3 tNGS solutions
研究概览
简要总结
The purpose of this observational multi-centre clinical study is to determine the performance accuracy and assess the operational characteristics of up to 3 tNGS end-to-end targeted sequencing solutions for DR-TB diagnosis at settings of intended use. It will be carried out at study sites in India, South Africa, and Georgia. The data obtained through this trial will be used only for evaluation of the accuracy and operational characteristics of tNGS solutions and will not be used in any way to inform the treatment of patients enrolled in the trial.
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
- •A clear TB-positive result by Xpert MTB/RIF OR Xpert MTB/RIF Ultra prior to enrolment, irrespective of RIF-resistance status, AND 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.
- •OR 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 OR C.Previously received >1 month of treatment for a prior TB episode OR D.Close contact with a known drug-resistant TB case AND 3.Willing to provide sputum AND 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) OR 2.Are pregnant or institutionalized or imprisoned.
结局指标
主要结局
Point estimates, with 95% confidence intervals, of sensitivity and specificity for rifampicin, isoniazid, fluoroquinolones, second-line injectables, and pyrazinamide resistance detection for up to 3 tNGS solutions
时间窗: Sputum samples will be collected from patient on the day of enrolment and the following day (Day 1 and Day 2) and pooled together to generate sediment. Frozen sediments will be processed using end-to-end targeted sequencing solutions no later than 1 month after collection.
次要结局
- 1.Detecting sensitivity and specificity (95%) for second-line resistance detection (bedaquiline, linezolid, clofazamine, streptomycin).(2.Performance of overall test success rate against Xpert MTB/RIF and Hain MTBDRplus/sl.)