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

Primary Purpose

Latent Tuberculosis Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BST
TST
QFT
T-spot
Sponsored by
Henry M. Jackson Foundation for the Advancement of Military Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Latent Tuberculosis Infection focused on measuring TB, tuberculosis diagnosis, TB screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fort Jackson, SC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All study participants

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 8, 2008
Last Updated
March 1, 2023
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Infectious Diseases Clinical Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT00804713
Brief Title
Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
Acronym
LTBI
Official Title
Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Infectious Diseases Clinical Research Program

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis Infection
Keywords
TB, tuberculosis diagnosis, TB screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
N/A
Enrollment
2017 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All study participants
Arm Type
Experimental
Arm Description
Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
Intervention Type
Drug
Intervention Name(s)
BST
Intervention Description
0.1 mcg/mL (1 dose) Battey skin test (BST) antigen administered using the Mantoux method.
Intervention Type
Drug
Intervention Name(s)
TST
Intervention Description
Administer TB Skin test (TST)
Intervention Type
Other
Intervention Name(s)
QFT
Other Intervention Name(s)
Quantiferon Gold-in-tube (QFT)
Intervention Description
Perform QFT TB test
Intervention Type
Other
Intervention Name(s)
T-spot
Other Intervention Name(s)
T-spot.TB test
Intervention Description
Perform T-Spot TB test
Primary Outcome Measure Information:
Title
TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines.
Description
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.
Time Frame
48-72 hrs post administration
Secondary Outcome Measure Information:
Title
Positive QFT-GIT Result
Description
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.
Time Frame
48-72 hours after enrollment
Other Pre-specified Outcome Measures:
Title
T-Spot Result
Description
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.
Time Frame
48-72 hours
Title
Battey Skin Test Result
Description
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.
Time Frame
48-72 hours after administration
Title
TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results
Time Frame
48-72 hours after adminstration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Mancuso, MD MPH
Organizational Affiliation
Uniformed Services University of the Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fort Jackson, SC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29207
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21765072
Citation
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.
Results Reference
derived

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

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