Clinical Trials Directory

Trials / Completed

CompletedNCT00804713

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
2,017 (actual)
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGBST0.1 mcg/mL (1 dose) Battey skin test (BST) antigen administered using the Mantoux method.
DRUGTSTAdminister TB Skin test (TST)
OTHERQFTPerform QFT TB test
OTHERT-spotPerform T-Spot TB test

Timeline

Start date
2009-03-01
Primary completion
2009-06-01
Completion
2022-08-01
First posted
2008-12-09
Last updated
2023-03-29
Results posted
2014-10-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00804713. Inclusion in this directory is not an endorsement.