Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
This trial is active, not recruiting.
|Condition||latent tuberculosis infection|
|Treatments||purified protein derivative-battey (ppd-b), tuberculin skin test, qft-git, t-spot|
|Sponsor||Uniformed Services University of the Health Sciences|
|Collaborator||Infectious Diseases Clinical Research Program|
|Start date||March 2009|
|End date||June 2009|
|Trial size||2500 participants|
|Trial identifier||NCT00804713, IDCRP-021|
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.
|Intervention model||crossover assignment|
|Masking||double blind (subject, outcomes assessor)|
TST induration will be interpreted relative to risk, in accordance with published CDC guidelines.
time frame: 48-72 hrs post administration
IGRA endpoints will be defined by using established cutoffs from the manufacturer.
time frame: 48-72 hours after enrollment
Male or female participants at least 18 years old.
- Any recruit, age 18 years or older, undergoing routine entry-level medical processing at Fort Jackson
- 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
|Official title||Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits|
|Principal investigator||James Mancuso, MD MPH|
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