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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Infectious Diseases Clinical Research Program
Information provided by (Responsible Party):
James Mancuso, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:
NCT00804713
First received: December 8, 2008
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Latent Tuberculosis Infection
Drug: BST
Drug: TST
Other: QFT
Other: T-spot

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits

Resource links provided by NLM:


Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines. [ Time Frame: 48-72 hrs post administration ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Positive QFT-GIT Result [ Time Frame: 48-72 hours after enrollment ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • T-Spot Result [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    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.

  • Battey Skin Test Result [ Time Frame: 48-72 hours after administration ] [ Designated as safety issue: No ]
    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.

  • TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results [ Time Frame: 48-72 hours after adminstration ] [ Designated as safety issue: No ]

Enrollment: 2017
Study Start Date: March 2009
Estimated Study Completion Date: July 2015
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All study participants
Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
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 Name: Quantiferon Gold-in-tube (QFT)
Other: T-spot
Perform T-Spot TB test
Other Name: T-spot.TB test

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804713

Locations
United States, South Carolina
Fort Jackson, SC
Columbia, South Carolina, United States, 29207
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Infectious Diseases Clinical Research Program
Investigators
Principal Investigator: James Mancuso, MD MPH Uniformed Services University of the Health Sciences
  More Information

No publications provided by Uniformed Services University of the Health Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James Mancuso, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT00804713     History of Changes
Other Study ID Numbers: IDCRP-021
Study First Received: December 8, 2008
Results First Received: May 19, 2014
Last Updated: October 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Uniformed Services University of the Health Sciences:
TB
tuberculosis diagnosis
TB screening

Additional relevant MeSH terms:
Communicable Diseases
Infection
Latent Tuberculosis
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on November 24, 2014