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

Latent Tuberculosis Infection Clinical Trial

— LTBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804713
• Other study ID #: IDCRP-021
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: August 2022

Study information

• Verified date: March 2023
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2017
• Est. completion date: August 2022
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Latent Tuberculosis
• Latent Tuberculosis Infection
• Tuberculosis

Intervention

Drug:
• BST
0.1 mcg/mL (1 dose) Battey skin test (BST) antigen administered using the Mantoux method.
• TST
Administer TB Skin test (TST)

Other:
• QFT
Perform QFT TB test
• T-spot
Perform T-Spot TB test

Locations

Country	Name	City	State
United States	Fort Jackson, SC	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	Infectious Diseases Clinical Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	T-Spot Result	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.	48-72 hours
Other	Battey Skin Test Result	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.	48-72 hours after administration
Other	TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results		48-72 hours after adminstration
Primary	TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines.	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.	48-72 hrs post administration
Secondary	Positive QFT-GIT Result	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.	48-72 hours after enrollment