NCT03712709已完成不适用
Prospective, Multicentre Trial to Assess the Diagnostic Accuracy of the Truenat Assays at Intended Settings of Use
Foundation for Innovative New Diagnostics, Switzerland4 个研究点 分布在 2 个国家目标入组 1,926 人开始时间: 2019年3月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,926
- 试验地点
- 4
- 主要终点
- Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay
研究概览
简要总结
Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis and rifampin resistance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case Detection Group:
- •Age 18 years or above
- •Clinical suspicion of pulmonary TB (including cough ≥2 week and at least 1 other symptom typical of TB);
- •Willingness to provide 3-4 sputum specimens at enrolment;
- •Willingness to have a trial follow-up visit approximately 2 months after enrolment;
- •Provision of informed consent.
- •Drug Resistant TB Group:
- •In addition to the criteria of the Case Detection Group, participants should also meet the following conditions:
- •Non-converting pulmonary TB cases (category I and category II failures)
排除标准
- •Case Detection Group:
- •Receipt of any dose of TB treatment within 60 days prior to enrolment (even if within last two days only).
- •Drug Resistant TB Group:
- •Receipt of any dose of MDR-TB treatment within 60 days prior to enrolment (even if within last two days only).
结局指标
主要结局
Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay
时间窗: Day 1
Estimate diagnostic accuracy of the Truenat assays (MTB and MTB Plus) for Mycobacterium tuberculosis (MTB) detection among individuals undergoing evaluation for pulmonary TB, using a culture reference standard
次要结局
- Time to TB detection and RIF resistance detection.(Day 1)
- Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay compared to Xpert MTB/RIF(Day 1)
- Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay(Day 1)
- Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay compared to Xpert MTB/RIF(Day 1)
研究者
研究点 (4)
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