Prospective Multicentre Evaluation of the Accuracy and Diagnostic Yield of the Fujifilm SILVAMP TB LAM (FujiLAM) Test for the Diagnosis of Tuberculosis in People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,731
- 试验地点
- 7
- 主要终点
- Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS.
研究概览
简要总结
This is a prospective, multicentre cohort study in which the accuracy and the diagnostic yield of the FujiLAM test will be assessed using a microbiological reference standard, an extended microbiological reference standard and a composite reference standard among inpatient and outpatient people living with HIV (PLHIV).
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
- •Adult PLHIV (≥18 years), irrespective of their CD4 count and antiretroviral therapy (ART) status, at risk of having pulmonary and/or extra-pulmonary TB
- •Inpatients: irrespective of TB symptoms
- •Outpatients: at least one of the symptoms suggestive of TB (as defined by WHO*)
- •written informed consent
- •willingness to have a trial follow-up visit at 2-3 and 6 months after enrolment (e.g. not planning to relocate)
排除标准
- •Current anti-TB treatment *
- •Any anti-TB treatment within 60 days prior to enrolment
- •Any isoniazid preventive therapy within 6 months prior to enrolment * Patients starting anti-TB treatment at the time of enrolment will not be excluded from the trial provided that all trial specimens are collected before starting the 3rd dose of treatment.
结局指标
主要结局
Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS.
时间窗: Day 1
Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined eMRS.
时间窗: Day 1
Diagnostic yield, with 95% confidence interval, of FujiLAM test among eMRS positive patients and AlereLAM, Smear and Ultra (sputum, urine) as comparators (on Day 1 specimens).
时间窗: Day 1
次要结局
未报告次要终点