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临床试验/NCT01622140
NCT01622140已完成不适用

Prospective Comparison of the Tuberculin Skin Test and Interferon-Gamma Release Assays in Diagnosing Infection With Mycobacterium Tuberculosis and in Predicting Progression to Tuberculosis

Centers for Disease Control and Prevention10 个研究点 分布在 1 个国家目标入组 21,334 人开始时间: 2012年10月最近更新:
适应症

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

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

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (10)

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