Trials / Completed
CompletedNCT00804713
Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,017 (actual)
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | T-spot | Perform T-Spot TB test |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2009-06-01
- Completion
- 2022-08-01
- First posted
- 2008-12-09
- Last updated
- 2023-03-29
- Results posted
- 2014-10-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00804713. Inclusion in this directory is not an endorsement.