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临床试验/NCT02639936
NCT02639936已完成不适用

Performance of a New Generation IGRA in Immunocompromised Individuals

Tuberculosis Network European Trialsgroup16 个研究点 分布在 10 个国家目标入组 2,663 人开始时间: 2015年12月最近更新:
适应症

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

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

发起方
Tuberculosis Network European Trialsgroup
申办方类型
Network
责任方
Principal Investigator
主要研究者

Martina Sester, PhD

Head of Department

Tuberculosis Network European Trialsgroup

研究点 (16)

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