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

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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

Tracking Information
First Submitted Date  ICMJE December 8, 2008
First Posted Date  ICMJE December 9, 2008
Results First Submitted Date  ICMJE May 19, 2014
Results First Posted Date  ICMJE October 15, 2014
Last Update Posted Date June 17, 2016
Study Start Date  ICMJE March 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2014)
TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2008)
TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines. [ Time Frame: 48-72 hrs post administration ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2014)
Positive QFT-GIT Result [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2008)
IGRA endpoints will be defined by using established cutoffs from the manufacturer.
Current Other Pre-specified Outcome Measures
 (submitted: October 14, 2014)
  • T-Spot Result [ Time Frame: 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.
  • Battey Skin Test Result [ Time Frame: 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.
  • TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results [ Time Frame: 48-72 hours after adminstration ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
Official Title  ICMJE Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE Latent Tuberculosis Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: All study participants
Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
Interventions:
  • Drug: BST
  • Drug: TST
  • Other: QFT
  • Other: T-spot
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 14, 2014)
2017
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2008)
2500
Estimated Study Completion Date  ICMJE August 2017
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00804713
Other Study ID Numbers  ICMJE IDCRP-021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Mancuso, Uniformed Services University of the Health Sciences
Study Sponsor  ICMJE Uniformed Services University of the Health Sciences
Collaborators  ICMJE Infectious Diseases Clinical Research Program
Investigators  ICMJE
Principal Investigator: James Mancuso, MD MPH Uniformed Services University of the Health Sciences
PRS Account Uniformed Services University of the Health Sciences
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP