Performance of a New Generation IGRA in Immunocompromised Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,663
- 试验地点
- 16
- 主要终点
- Sensitivity
研究概览
简要总结
Evaluation of a new ELISA based interferon-gamma release assay (QuantiFERON TB plus In-tube test) in immunocompromized patients
详细描述
This study is designed to evaluate the performance of a new ELISA based QuantiFERON-TB plus In-tube test to identify M. tuberculosis specific immune Responses as evidence of latent infection with M. tuberculosis in immunosuppressed populations. Both qualitative and quantitative test results will be related to the level of immunodeficiency and to the presence of risk factors for prior exposure with M. tuberculosis. In addition, patients with active tuberculosis (both immunocompetent and immunocompromised individuals) will be included to evaluate a potential increase in sensitivity in these groups. Immunocompetent individuals with low risk of exposure will be analysed as a proxy to estimate specificity. Finally, this study will be extended to longitudinally assess the predictive value of a positive blood test for progression to active disease.
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
- 是
入选标准
- •Individuals as specified for the study Population
- •Written informed consent
排除标准
- •<18 years of age
结局指标
主要结局
Sensitivity
时间窗: 2 years
The percentage of positive test results will be quantified among controls and patients with active tuberculosis.
Specificity
时间窗: 2 years
The percentage of negative test results will be quantified among controls and patients without risk factors for M. tuberculosis exposure.
Progression
时间窗: 4 years
The number of individuals progressing to tuberculosis will be quantified depending on the test result at the time of screening and depending on preventive chemotherapy
Indeterminate results
时间窗: 2 years
The percentage of indeterminate results will be quantified in immunocompetent and immunocompromised patients
Association with exposure
时间窗: 2 years
Results from QFT-Plus assay will be associated with risk factors for M. tuberculosis exposure
次要结局
未报告次要终点
研究者
Martina Sester, PhD
Head of Department
Tuberculosis Network European Trialsgroup
