Multicentre trial to assess theperformance of centralized assaysolutions for detection of MTB and resistance to Rifampin and Isoniazid
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- 1.Diagnostic accuracy for MTB detection: clinical sensitivity
研究概览
简要总结
Cross-sectional diagnostic accuracy study with culture, phenotypic DST and sequencing as reference standards and Xpert MTB/RIF (or Ultra) as a comparator. Results from the FluoroType MTBDR V2 assay will not be used to make clinical decisions. Participants in whom pulmonary TB is suspected. Additionally,
well-characterized RIF-resistant and INH-resistant samples will be used to supplement drug-resistant cases. The primary Objective is to Estimate diagnostic accuracy of FluoroType MTBDR V2 assay for MTB detection for smear-positive and smear negative TB, including Xpert MTB/RIF (or Ultra) as a comparator and culture as the reference standard and to Estimate diagnostic accuracy of FluoroType MTBDR V2 assay for resistance detection (RIF/INH) with sequencing and phenotypic DST as the reference standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Aged Equal ore more than 18 years.
- •Clinical suspicion of pulmonary TB including productive cough of equal or more than 2 weeks and equal or more than 1 week for other symptom typical of pulmonary TB listed below: 2.
- •Contact with active case 2.
- •Haemoptysis 2.
- •Recent weight Loss 2.
- •Chest Pain 2.
- •Night sweats 2.
- •Loss of appetite 3) Willing to Provide two sputum specimens at enrollment 4) Willing to provide informed consent.
排除标准
- •Only extra-pulmonary TB signs & symptoms 2) Receipt of any dose of TB treatment within 6 months prior to enrolment or currently on TB treatment.
结局指标
主要结局
1.Diagnostic accuracy for MTB detection: clinical sensitivity
时间窗: Baseline
and specificity by smear-status measured against
时间窗: Baseline
mycobacterial culture as the reference standard.
时间窗: Baseline
次要结局
- 1) Diagnostic accuracy for MTB detection:clinical point estimates of sensitivity and specificity measured against(mycobacterial culture as the reference standard by sub gr oup.)