Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,017
- 试验地点
- 1
- 主要终点
- TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines.
研究概览
简要总结
The overall objective of this study is to assess the feasibility and potential impact of using a targeted testing approach and 2 interferon-gamma release assays (IGRA) to screen for latent tuberculosis (TB) infection (LTBI) among military recruits. The current policy of universal application of the Mantoux tuberculin skin test (TST) to screen for LTBI may result in many TST reactions among recruits who are at low risk for LTBI. The central hypothesis is that targeted testing by use of the questionnaire will reduce unnecessary testing of low-risk recruits without affecting the identification of higher-risk recruits. The secondary hypothesis is that many discordant results between the TST and IGRA may be explained by cross-reactivity to non-tuberculous mycobacteria (NTM) with the TST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
All study participants received 4 tests, including the use of two skin tests, one on each arm. However, the participant and outcomes assessors were blinded to which skin test was placed on which arm to avoid bias in assessment of the outcomes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any recruit, age 18 years or older, undergoing routine entry-level medical processing at Fort Jackson
排除标准
- •If they have history of severe reactions to TST (e.g., blistering, scar, or symptoms of immediate hypersensitivity)
- •If they are unwilling to provide written consent for the study
- •If they are unwilling to provide Health Insurance Portability and Accountability Act (HIPAA) authorization
研究组 & 干预措施
All study participants
Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
干预措施: BST (Drug)
All study participants
Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
干预措施: TST (Drug)
All study participants
Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
干预措施: QFT (Other)
All study participants
Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
干预措施: T-spot (Other)
结局指标
主要结局
TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines.
时间窗: 48-72 hrs post administration
Risk stratification and test result. Risk was stratified by the use of risk factors identified by questionnaire according to the 5, 10 and 15 mm criteria (CDC Morbidity and Mortality Weekly Report Recommendations and Reports 2000. Targeted Testing for Latent Tuberculosis Infection.) The number of 1803 is used here because that is the number for which valid results were available for all 4 tests. The number presented in each category is the number of participants that had positive results. We are only presented a risk stratified interpretation for the TST (not the QFT, T-spot, and BST) because that is the only test for which this methodology is accepted in scientific and medical use. It is also the only test for which we had pre-specified the use of this methodology in the protocol.
次要结局
- Positive QFT-GIT Result(48-72 hours after enrollment)