Prospective Comparison of the Tuberculin Skin Test and Interferon-Gamma Release Assays in Diagnosing Infection With Mycobacterium Tuberculosis and in Predicting Progression to Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21,334
- 试验地点
- 10
- 主要终点
- Tuberculosis disease at 6 months
研究概览
简要总结
This is a prospective cohort study of persons tested for latent tuberculosis infection at either high risk for exposure to Mycobacterium tuberculosis or high risk for progression to tuberculosis disease. The study will assess the relative performance and cost of three diagnostic tests for latent tuberculosis infection (tuberculin skin test, QuantiFERON-TB Gold In-Tube, and T-SPOT.TB) and will examine the rates of positive results among the cohort. This study will also determine the risk and rate of progression to active TB disease, overall and by the results of the three tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Tuberculosis disease at 6 months
时间窗: 6 months
Tuberculosis disease at 12 months
时间窗: 12 months
Latent tuberculosis infection
时间窗: 3 days
Tuberculosis disease at 24 months
时间窗: 24 months
Tuberculosis disease at 18 months
时间窗: 18 months
次要结局
未报告次要终点
