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| Name | Class |
|---|---|
| Infectious Diseases Clinical Research Program | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All study participants | Experimental | Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BST | Drug | 0.1 mcg/mL (1 dose) Battey skin test (BST) antigen administered using the Mantoux method. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48-72 hours after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| T-Spot Result | 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. | 48-72 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Mancuso, MD MPH | Uniformed Services University of the Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fort Jackson, SC | Columbia | South Carolina | 29207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21765072 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Subjects administered the tuberculosis skin test (TST), Battey skin test, Quantiferon Gold-in-tube (QFT-GIT), and T-Spot |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
recruits at Fort Jackson, SC in 2009 between April 1 and June 11
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Subjects administered the Tuberculosis skin test (TST), Battey skin test, QFT-GIT, and T-spot |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 48-72 hrs post administration |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Participants | Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot |
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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).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Mancuso | USUHS | 301-295-3734 | james.mancuso@usuhs.edu |
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| ID | Term |
|---|---|
| D055985 | Latent Tuberculosis |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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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.
| TST | Drug | Administer TB Skin test (TST) |
|
| QFT | Other | Perform QFT TB test |
|
|
| T-spot | Other | Perform T-Spot TB test |
|
|
| Battey Skin Test Result |
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. |
| 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 |
| years |
|
| Sex/Gender, Customized | sex of participants. The number doesn not equal 1978 because of missing responses on the questionnaire. | Number | participants |
|
| Prevalence of tuberculosis (TB) in country of birth | Prevalence of TB per 100,000 population | Number | participants |
|
Subjects administered the TB skin test
Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot
|
|
| Secondary | 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. | Posted | Number | participants | 48-72 hours after enrollment |
|
|
|
| Other Pre-specified | T-Spot Result | 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. | Posted | Number | participants | 48-72 hours |
|
|
|
| Other Pre-specified | Battey Skin Test Result | 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. | Posted | Number | participants | 48-72 hours after administration |
|
|
|
| Other Pre-specified | TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results | Posted | Number | participants | 48-72 hours after adminstration |
|
|
|
| 0 |
| 1,978 |
| 0 |
| 1,978 |
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| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |