COMPArison of Screening Strategies for Active TuBerculosis (COMPASS-TB)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 580
- 试验地点
- 1
- 主要终点
- Diagnostic performance (specificity) of the combination of IGRA and Chest CT scan
研究概览
简要总结
The study is an evaluation of the diagnostic performance of different tests and their association in order to confirm or exclude active tuberculosis.
详细描述
Background : diagnostic methods to distinguish between latent TB infection (LTBI) and active TB disease remains challenging. Data are scarce concerning the positive predictive value of Current diagnostic approaches, including Interferon-Gamma Release Assay (IGRA) and chest radiography, which is often very low. Computed tomography (CT) scanning, although not recommended by the World Health Organization (WHO) for TB diagnosis, may be of high interest in our high-income low-burden countries. This study assess the performance of the combination of CT scanning and IGRA to diagnose active pulmonary TB and identifies discriminatory CT scan features indicative of active disease.
Methods : A retrospective study was conducted on 580 patients clinically suspected of TB or in contact with bacteriologically confirmed cases (index cases). Patients underwent IGRA testing, thoracic CT scans, and respiratory (or other organs) samples culture. CT scan findings were blindly analyzed, and a composite score combining significant radiological signs with IGRA results was constructed. Diagnostic performance measures, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), were calculated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Major patients who received the following examinations at the Montpellier University Hospital for tuberculosis screening (clinical suspicion and/or contact with a person with active tuberculosis):
- •Chest X-ray AND
- •Chest CT scan AND
- •Mycobacteriology examination of respiratory or tissue sample (direct/culture/GenXpert) AND
- •IGRA test (Quantiferon)
排除标准
- 未提供
结局指标
主要结局
Diagnostic performance (specificity) of the combination of IGRA and Chest CT scan
时间窗: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
specificity
Diagnostic performance (sensitivity) of the combination of IGRA and Chest CT scan
时间窗: Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis
Sensitivity
次要结局
- Positive Predictive value of the combination of IGRA and Chest CT scan(Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis)
- Negative Predictive value of the combination of IGRA and Chest CT scan(Over 12 weeks from the initial medical contact due to suspected tuberculosis to the confirmation or exclusion of this diagnosis)