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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00804713
Recruitment Status : Unknown
Verified May 2016 by James Mancuso, Uniformed Services University of the Health Sciences.
Recruitment status was:  Active, not recruiting
First Posted : December 9, 2008
Results First Posted : October 15, 2014
Last Update Posted : June 17, 2016
Sponsor:
Collaborator:
Infectious Diseases Clinical Research Program
Information provided by (Responsible Party):
James Mancuso, Uniformed Services University of the Health Sciences

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Screening
Condition Latent Tuberculosis Infection
Interventions Drug: BST
Drug: TST
Other: QFT
Other: T-spot
Enrollment 2017
Recruitment Details  
Pre-assignment Details 39 participants were enrolled but lost to follow-up before skin testing or blood draw were performed. This was due to the administrative requirements of the basic training setting, not because of the study itself.
Arm/Group Title All Study Participants
Hide Arm/Group Description Subjects administered the tuberculosis skin test (TST), Battey skin test, Quantiferon Gold-in-tube (QFT-GIT), and T-Spot
Period Title: Overall Study
Started 1978
Completed 1978
Not Completed 0
Arm/Group Title All Study Participants
Hide Arm/Group Description Subjects administered the Tuberculosis skin test (TST), Battey skin test, QFT-GIT, and T-spot
Overall Number of Baseline Participants 1978
Hide Baseline Analysis Population Description
recruits at Fort Jackson, SC in 2009 between April 1 and June 11
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1978 participants
21.8  (4.6)
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1978 participants
Female 681
Male 1294
[1]
Measure Description: sex of participants. The number doesn not equal 1978 because of missing responses on the questionnaire.
Prevalence of tuberculosis (TB) in country of birth   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1978 participants
<20 per 100,000 1811
20-99 per 100,000 62
>=100 per 100,000 105
[1]
Measure Description: Prevalence of TB per 100,000 population
1.Primary Outcome
Title TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Study Participants
Hide Arm/Group Description:

Subjects administered the TB skin test

Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot

Overall Number of Participants Analyzed 1803
Measure Type: Number
Unit of Measure: participants
High 2
Medium 37
Low 20
2.Secondary Outcome
Title Positive QFT-GIT Result
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title QFT-GIT
Hide Arm/Group Description:

Subjects administered the QFT-GIT TB test

QFT-GIT: Perform QFT-GIT TB test

Overall Number of Participants Analyzed 1781
Measure Type: Number
Unit of Measure: participants
Positive 36
Negative 1745
3.Other Pre-specified Outcome
Title T-Spot Result
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Study Participants
Hide Arm/Group Description:

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

All study participants: 0.1 mcg/mL (1 dose) Battey skin test antigen administered using the Mantoux method.

All study participants: Administer TB Skin test

All study participants: Perform QFT-GIT TB test

All study participants: Perform T-Spot TB test

Overall Number of Participants Analyzed 1781
Measure Type: Number
Unit of Measure: participants
Positive 34
Negative 1747
4.Other Pre-specified Outcome
Title Battey Skin Test Result
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Study Participants
Hide Arm/Group Description:

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

All study participants: 0.1 mcg/mL (1 dose) Battey skin test antigen administered using the Mantoux method.

All study participants: Administer TB Skin test

All study participants: Perform QFT-GIT TB test

All study participants: Perform T-Spot TB test

Overall Number of Participants Analyzed 1781
Measure Type: Number
Unit of Measure: participants
Positive 203
Negative 1578
5.Other Pre-specified Outcome
Title TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results
Hide Description [Not Specified]
Time Frame 48-72 hours after adminstration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Study Participants
Hide Arm/Group Description:

Subjects administered the TB skin test

Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot

Overall Number of Participants Analyzed 1781
Measure Type: Number
Unit of Measure: participants
Positive 48
Negative 1733
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Study Participants
Hide Arm/Group Description Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%)
Total   0/1978 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Study Participants
Affected / at Risk (%)
Total   0/1978 (0.00%) 
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).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James Mancuso
Organization: USUHS
Phone: 301-295-3734
EMail: james.mancuso@usuhs.edu
Layout table for additonal information
Responsible Party: James Mancuso, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT00804713    
Other Study ID Numbers: IDCRP-021
First Submitted: December 8, 2008
First Posted: December 9, 2008
Results First Submitted: May 19, 2014
Results First Posted: October 15, 2014
Last Update Posted: June 17, 2016