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

NCT00804713 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2017

Last updated 2023-03-29

Study results available
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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

  • Latent Tuberculosis Infection

Interventions

DRUG

BST

0.1 mcg/mL (1 dose) Battey skin test (BST) antigen administered using the Mantoux method.

DRUG

TST

Administer TB Skin test (TST)

OTHER

QFT

Perform QFT TB test

OTHER

T-spot

Perform T-Spot TB test

Sponsors & Collaborators

  • Infectious Diseases Clinical Research Program

    collaborator OTHER

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    lead OTHER

Principal Investigators

  • James Mancuso, MD MPH · Uniformed Services University of the Health Sciences

Study Design

Allocation
NA
Purpose
SCREENING
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-06-30
Completion
2022-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00804713 on ClinicalTrials.gov