NCT06485895招募中不适用
Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- specificity of TB-IGRA 2nd generation test
研究概览
简要总结
Methodology This is a single-center study carried out as part of routine patient care.
The aim of the study is to determine the performance of the 2nd generation TB-IGRA test in the diagnosis of tuberculosis.
详细描述
It is planned to include 500 patients. An enrolment of 455 subjects will enable us to demonstrate sensitivity-specificity levels of 92% for a 95% confidence interval and a 0.05 degree of precision. To take account of non-analyzable samples or tests, the investigator will include 500 subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Individual at least 18 years of age
- •Patient presenting for treatment of tuberculosis disease
- •Having undergone or benefiting from screening for tuberculosis using a medically prescribed reference IGRA test.
- •Informed patient who has not expressed opposition to participating in the study.
- •French-speaking patient with unambiguous understanding of oral and written instructions.
排除标准
- •Persons in a period of exclusion from another study
- •Pregnant, parturient or breast-feeding women;
- •Person deprived of liberty by judicial or administrative decision
研究组 & 干预措施
TUBERCULOSIS (LATENTE OR ACTIVE) ARM
Experimental
干预措施: test IGRA (Diagnostic Test)
TUBERCULOSIS (LATENTE OR ACTIVE) ARM
Experimental
干预措施: TEST QUATIFERON TB Gold Plus (Diagnostic Test)
结局指标
主要结局
specificity of TB-IGRA 2nd generation test
时间窗: 24 MONTHS
sensitivity of TB-IGRA 2nd generation test
时间窗: 24 MONTHS
次要结局
未报告次要终点
研究者
研究点 (1)
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