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

NCT00804713 | Completed Results

• 1 other identifier: IDCRP-021
• Study Type: interventional
• Target: 2,017
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

TB; tuberculosis diagnosis; TB screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Positive QFT-GIT Result

  48-72 hours after enrollment

Other Outcomes (3)

• T-Spot Result

  48-72 hours

• Battey Skin Test Result

  48-72 hours after administration

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

  48-72 hours after adminstration

Study Arms (1)

All study participants

EXPERIMENTAL

Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot

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

Interventions

BST DRUG

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

All study participants

TST DRUG

Administer TB Skin test (TST)

All study participants

QFT OTHER

Perform QFT TB test

Also known as: Quantiferon Gold-in-tube (QFT)

All study participants

T-spot OTHER

Perform T-Spot TB test

Also known as: T-spot.TB test

All study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Infectious Diseases Clinical Research Program: collaborator

Study Sites (1)

Fort Jackson, SC

Columbia, South Carolina, 29207, United States

Location

Related Publications (1)

• Mancuso JD, Tribble D, Mazurek GH, Li Y, Olsen C, Aronson NE, Geiter L, Goodwin D, Keep LW. Impact of targeted testing for latent tuberculosis infection using commercially available diagnostics. Clin Infect Dis. 2011 Aug 1;53(3):234-44. doi: 10.1093/cid/cir321.

  PMID: 21765072 DERIVED

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

A limitation of this study is the lack of a gold standard for determining the presence of M. tuberculosis infection, making it difficult to assess the true significance of discordance between TST and the interferon-gamma release assays (IGRAs).

Results Point of Contact

• Title: James Mancuso
• Organization: USUHS

james.mancuso@usuhs.edu

301-295-3734

Study Officials

• James Mancuso, MD MPH

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All study participants received 4 tests, including the use of two skin tests, one on each arm. However, the participant and outcomes assessors were blinded to which skin test was placed on which arm to avoid bias in assessment of the outcomes.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: March 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2022
• Last Updated: March 29, 2023
• Results First Posted: October 15, 2014

Record last verified: 2023-03

Locations

US (1)