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临床试验/NCT00402402
NCT00402402已完成4 期

Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing for Detecting Latent Mycobacterium Tuberculosis Infection in Patients With Chronic Liver Disease Awaiting Liver Transplantation

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
300
试验地点
2
主要终点
Concordance between the Quantiferon-TB Gold assay and the tuberculin skin test

研究概览

简要总结

The purpose of the study is to estimate the usefulness of the QuantiFERON®-TB Gold test for the diagnosis of latent tuberculosis infection in liver transplant candidates by correlating the test results with risk factors for LTBI

详细描述

Tuberculosis (TB) is an important cause of morbidity and mortality in organ transplant recipients. Although the tuberculin skin test (TST) is recommended for screening of latent tuberculosis infection (LTBI) in all candidates for liver transplantation, the performance of the TST in this setting is less than optimal, due to a lack of specificity and a lack of sensitivity in a population that is relatively immunocompromised. Recently, a new test named QuantiFERON-TB Gold (QFT-G) has been approved for the diagnosis of LTBI. QFT-G is expected to be more specific than TST. However, there are no studies defining the performance of QFT-G in a population of patients on a waiting list for liver transplantation. We plan to estimate the usefulness of the QFT-G test for the diagnosis of LTBI in a cohort of patients with end-stage liver disease. We hypothesize that the QFT-G test will correlate better with the risk of LTBI.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Chronic liver disease on the waiting list or being wait listed for liver transplantation

排除标准

  • Unable to provide informed consent
  • Previous history of immediate hypersensitivity to TST
  • Previous severe local ulceration with TST
  • Suspected active TB

结局指标

主要结局

Concordance between the Quantiferon-TB Gold assay and the tuberculin skin test

Correlation of the test results to the patient's risk of latent TB infection

次要结局

  • Factors associated with discordance between the TST and the QFT-G test
  • Frequency of anergy in this patient population

研究者

申办方类型
Other

研究点 (2)

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