NCT03072576已完成不适用
A Multicentre Study of the Diagnostic Accuracy and Feasibility of the Xpert Ultra for Detection of TB and Rifampin Resistance in Adults Suspected of Having Pulmonary TB
Foundation for Innovative New Diagnostics, Switzerland6 个研究点 分布在 4 个国家目标入组 1,400 人开始时间: 2016年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,400
- 试验地点
- 6
- 主要终点
- Difference in sensitivity and specificity (ability to correctly identify those with TB and those without TB) between Xpert Ultra and Xpert MTB/ for Mycobacterium tuberculosis (MTB) detection (non-inferiority endpoint)
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
- Prospective
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
- •Age 18 years or above;
- •Provision of informed consent;
- •Willingness to provide 4 sputum specimens at enrolment;
- •Willingness to have a study follow-up visit approximately 42 to 70 days after enrolment
- •Clinical suspicion of pulmonary TB (including cough ≥2 weeks and at least 1 other symptom typical of TB)
排除标准
- •Receipt of any dose of TB treatment within 6 months prior to enrolment
- •Participants for whom, at the time of enrolment, the follow-up visit is judged to be poorly feasible (e.g. individuals planning to relocate)
- •Drug-Resistant TB Group
- •Inclusion Criteria:
- •Age 18 years or above;
- •Provision of informed consent;
- •Willingness to provide 4 sputum specimens at enrolment;
- •Non-converting pulmonary TB cases (category I and category II failures) or multi-drug resistant (MDR) suspect* (based on World Health Organization definition), i.e. at least one of the following: i) retreatment cases, ii) active TB cases that are MDR-contacts and iii) patients at high risk for MDR-TB as determined by local program (e.g. prisoners)
- •Exclusion Criteria:
结局指标
主要结局
Difference in sensitivity and specificity (ability to correctly identify those with TB and those without TB) between Xpert Ultra and Xpert MTB/ for Mycobacterium tuberculosis (MTB) detection (non-inferiority endpoint)
时间窗: Day 1
次要结局
- Difference in sensitivity and specificity (ability to correctly identify those with TB resistant to Rifampin and those with TB susceptible to Rifampin) of Xpert Ultra and Xpert MTB/RIF for detection of RIF resistance(Day 1)
- Sensitivity of Xpert Ultra for MTB detection (ability to correctly identify those with TB i.e. true positives), stratified by smear status(Day 1)
- Sensitivity and specificity (ability to correctly identify those with TB resistant to Rifampin and those with TB susceptible to Rifampin) of Xpert Ultra for detection of Rifampin (RIF) resistance(Day 1)
- Proportion of test attempts that do not yield a determinate result for Xpert Ultra and for Xpert MTB/RIF(Day 1)
研究者
研究点 (6)
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