Clinical Trial: Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits

Brief Summary: 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.

Detailed Summary:
Sponsor: Uniformed Services University of the Health Sciences

Current Primary Outcome: TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines. [ Time Frame: 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.



Original Primary Outcome: TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines. [ Time Frame: 48-72 hrs post administration ]

Current Secondary Outcome: Positive QFT-GIT Result [ Time Frame: 48-72 hours after enrollment ]

The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.


Original Secondary Outcome: IGRA endpoints will be defined by using established cutoffs from the manufacturer.

Information By: Uniformed Services University of the Health Sciences

Dates:
Date Received: December 8, 2008
Date Started: March 2009
Date Completion: August 2017
Last Updated: May 13, 2016
Last Verified: May 2016