N/A
Completed N=1,978
Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
Source: ClinicalTrials.gov NCT00804713 ↗Enrolled (actual)
1,978
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines. — 2; 37; 20 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines. |
2; 37; 20 | — |
| SECONDARY Positive QFT-GIT Result |
36; 1745 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00804713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.