Skip to main content
OpenTrials
Completed

NCT Number: NCT00804713

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Latent Tuberculosis Infection Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Mycobacterium Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fort Jackson, SC

Columbia, South Carolina, 29207, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BST

Drug

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

TST

Drug

Administer TB Skin test (TST)

QFT

Other

Perform QFT TB test

Other names: Quantiferon Gold-in-tube (QFT)

T-spot

Other

Perform T-Spot TB test

Other names: T-spot.TB test

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. T-Spot Result

    Time frame: 48-72 hours

    Positive T-Spot results. 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.

  2. Battey Skin Test Result

    Time frame: 48-72 hours after administration

    Battey skin test positive results defined as >= 100 mm reaction. 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.

  3. TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results

    Time frame: 48-72 hours after adminstration

Sponsors and collaborators

Lead sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Other

Collaborators

  • Infectious Diseases Clinical Research Program

Registry information

Acronym: LTBI

Important dates

Study start
2009
Primary completion
2009
Study completion
2022
First posted
Dec 9, 2008
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.