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临床试验/NCT00491933
NCT00491933Unknown不适用

Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing in the Assessment of Latent Mycobacterium Tuberculosis Infection in Patients Candidate to Treatment or Treated With TNFα Antagonists

ASST Fatebenefratelli Sacco2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Concordance between the QFT-G assay and the tuberculin skin test

研究概览

简要总结

The purpose of this study is to evaluate the value of Quantiferon-TB Gold (QFT-G) assay in the screening for latent tuberculosis infection (LTBI) in rheumatologic patients due to start or on treatment with TNFα antagonists. The results of QFT-G will be compared to tuberculin skin testing (TST) and correlated to clinical and demographic data. The study hypothesis is that the inclusion of QTF-G in the screening strategy will allow a more accurate assessment of LTBI infection.

详细描述

Treatment with TNFα antagonists is associated with an increased risk of active tuberculosis. Screening for LTBI and adherence to published guidelines have been shown to greatly decrease the risk of active tuberculosis. However, the best screening strategy is still object of debate. The validity of TST in patients on immunosuppressive treatment has been questioned. Recently, interferon-γ assays based on RD1-specific antigens have shown to cause less confounding by BCG vaccination and from most non-tuberculosis mycobacteria than TST, and have shown improved accuracy over TST in several settings. However, data on their use in rheumatologic patients are limited, and their superiority in patients on immunosuppressive treatment is unclear since indeterminate results may limit their clinical usefulness in this setting.

Purpose of the study is to investigate the added value of the inclusion of QTF-G assay in the screening strategy of LTBI in rheumatologic patients before and during treatment with TNFα antagonists.

The study will compare the results of TST with the results of QFT-G assay in rheumatologic patients being evaluated for treatment with anti-TNFα agents or already on treatment with anti-TNFα agents. The rate of positive and negative results of the two test will be compared, end results correlated to clinical and demographic variables.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with rheumatological diseases being evaluated for treatment with TNFα antagonists or on treated with TNFα antagonists

排除标准

  • Unable to sign informed consent
  • Known hypersensitivity to tuberculin

结局指标

主要结局

Concordance between the QFT-G assay and the tuberculin skin test

Correlation of the test results to the patient's risk of LTBI

次要结局

  • Factors associated with discordance between the TST and the QFT-G test
  • Frequency of indeterminate results

研究者

申办方类型
Other

研究点 (2)

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