Trial Outcomes & Findings for Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits (NCT NCT00804713)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2017 participants

Primary outcome timeframe

48-72 hrs post administration

Results posted on

2023-03-29

Participant Flow

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.

Participant milestones

Participant milestones
Measure	All Study Participants Subjects administered the tuberculosis skin test (TST), Battey skin test, Quantiferon Gold-in-tube (QFT-GIT), and T-Spot
Overall Study STARTED	1978
Overall Study COMPLETED	1978
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=1978 Participants Subjects administered the Tuberculosis skin test (TST), Battey skin test, QFT-GIT, and T-spot
Age, Continuous	21.8 years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex/Gender, Customized Female	681 participants n=5 Participants
Sex/Gender, Customized Male	1294 participants n=5 Participants
Prevalence of tuberculosis (TB) in country of birth <20 per 100,000	1811 participants n=5 Participants
Prevalence of tuberculosis (TB) in country of birth 20-99 per 100,000	62 participants n=5 Participants
Prevalence of tuberculosis (TB) in country of birth >=100 per 100,000	105 participants n=5 Participants

PRIMARY outcome

Timeframe: 48-72 hrs post administration

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.

Outcome measures

Outcome measures
Measure	All Study Participants n=1803 Participants Subjects administered the TB skin test Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot
TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines. High	2 participants
TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines. Medium	37 participants
TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines. Low	20 participants

SECONDARY outcome

Timeframe: 48-72 hours after enrollment

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.

Outcome measures

Outcome measures
Measure	All Study Participants n=1781 Participants Subjects administered the TB skin test Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot
Positive QFT-GIT Result Positive	36 participants
Positive QFT-GIT Result Negative	1745 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 48-72 hours

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.

Outcome measures

Outcome measures
Measure	All Study Participants n=1781 Participants Subjects administered the TB skin test Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot
T-Spot Result Positive	34 participants
T-Spot Result Negative	1747 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 48-72 hours after administration

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.

Outcome measures

Outcome measures
Measure	All Study Participants n=1781 Participants Subjects administered the TB skin test Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot
Battey Skin Test Result Positive	203 participants
Battey Skin Test Result Negative	1578 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 48-72 hours after adminstration

Outcome measures

Outcome measures
Measure	All Study Participants n=1781 Participants Subjects administered the TB skin test Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot
TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results Positive	48 participants
TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results Negative	1733 participants

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Mancuso

USUHS

Phone: 301-295-3734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place