Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose screening
Arm
(Active Comparator)
Subjects administered the TB skin test
tuberculin skin test
Administer TB Skin test
(Experimental)
Subjects administered the T-Spot TB test
t-spot
Perform T-Spot TB test
(Experimental)
Subjects administered the QFT-GIT TB test
qft-git Quantiferon Gold-in-tube
Perform QFT-GIT TB test
(Experimental)
Administration of the PPD-B skin test
purified protein derivative-battey (ppd-b)
0.1 mcg/mL (1 dose) administered using the Mantoux method.

Primary Outcomes

Measure
TST induration will be interpreted relative to risk, in accordance with published CDC guidelines.
time frame: 48-72 hrs post administration

Secondary Outcomes

Measure
IGRA endpoints will be defined by using established cutoffs from the manufacturer.
time frame: 48-72 hours after enrollment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
Principal investigator James Mancuso, MD MPH
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Uniformed Services University of the Health Sciences.