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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Infectious Diseases Clinical Research Program
Information provided by (Responsible Party):
James Mancuso, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:
NCT00804713
First received: December 8, 2008
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Latent Tuberculosis Infection
Drug: Purified Protein Derivative-Battey (PPD-B)
Drug: Tuberculin Skin Test
Other: QFT-GIT
Other: T-Spot

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits

Resource links provided by NLM:


Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • TST induration will be interpreted relative to risk, in accordance with published CDC guidelines. [ Time Frame: 48-72 hrs post administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IGRA endpoints will be defined by using established cutoffs from the manufacturer. [ Time Frame: 48-72 hours after enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: March 2009
Estimated Study Completion Date: July 2015
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tuberculin Skin Test
Subjects administered the TB skin test
Drug: Tuberculin Skin Test
Administer TB Skin test
Experimental: T-Spot
Subjects administered the T-Spot TB test
Other: T-Spot
Perform T-Spot TB test
Experimental: QFT-GIT
Subjects administered the QFT-GIT TB test
Other: QFT-GIT
Perform QFT-GIT TB test
Other Name: Quantiferon Gold-in-tube
Experimental: Purified Protein Derivative-Battey (PPD-B)
Administration of the PPD-B skin test
Drug: Purified Protein Derivative-Battey (PPD-B)
0.1 mcg/mL (1 dose) administered using the Mantoux method.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804713

Locations
United States, South Carolina
Fort Jackson, SC
Columbia, South Carolina, United States, 29207
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Infectious Diseases Clinical Research Program
Investigators
Principal Investigator: James Mancuso, MD MPH Uniformed Services University of the Health Sciences
  More Information

No publications provided by Uniformed Services University of the Health Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James Mancuso, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT00804713     History of Changes
Other Study ID Numbers: IDCRP-021
Study First Received: December 8, 2008
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Uniformed Services University of the Health Sciences:
TB
tuberculosis diagnosis
TB screening

Additional relevant MeSH terms:
Infection
Communicable Diseases
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014