Prospective Comparison of the Tuberculin Skin Test and Interferon-Gamma Release Assays in Diagnosing Infection With Mycobacterium Tuberculosis and in Predicting Progression to Tuberculosis

Completed

• Conditions: Latent Tuberculosis Infection; Tuberculosis

• Registration Number: NCT01622140
• Lead Sponsor: Centers for Disease Control and Prevention

Brief Summary

This is a prospective cohort study of persons tested for latent tuberculosis infection at either high risk for exposure to Mycobacterium tuberculosis or high risk for progression to tuberculosis disease. The study will assess the relative performance and cost of three diagnostic tests for latent tuberculosis infection (tuberculin skin test, QuantiFERON-TB Gold In-Tube, and T-SPOT.TB) and will examine the rates of positive results among the cohort. This study will also determine the risk and rate of progression to active TB disease, overall and by the results of the three tests.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-18
• Study Start: 2012-10
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21334

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tuberculosis disease at 6 months	6 months
Tuberculosis disease at 12 months	12 months
Latent tuberculosis infection	3 days
Tuberculosis disease at 24 months	24 months
Tuberculosis disease at 18 months	18 months

Trial Locations

Locations (10)

University of North Texas Health Science Center; 🇺🇸 Fort Worth, Texas, United States

California Department of Public Health; 🇺🇸 Richmond, California, United States

Maricopa County Department of Public Health; 🇺🇸 Phoenix, Arizona, United States

Denver Health and Hospitals Authority; 🇺🇸 Denver, Colorado, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Maryland Department of Public Health; 🇺🇸 Baltimore, Maryland, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Public Health Seattle-King County; 🇺🇸 Seattle, Washington, United States

University of Florida Board of Trustees; 🇺🇸 Gainesville, Florida, United States

Hawaii Department of Health; 🇺🇸 Honolulu, Hawaii, United States