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

H

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status

Completed

Conditions

Latent Tuberculosis Infection

Treatments

Other: T-spot
Other: QFT
Drug: TST
Drug: BST

Study type

Interventional

Funder types

Other

Identifiers

NCT00804713
IDCRP-021

Details and patient eligibility

About

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.

Enrollment

2,017 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Any recruit, age 18 years or older, undergoing routine entry-level medical processing at Fort Jackson

Exclusion criteria

  • 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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Double Blind

2,017 participants in 1 patient group

All study participants
Experimental group
Description:
Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
Treatment:
Other: QFT
Other: T-spot
Drug: BST
Drug: TST

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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