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

NCT01622140 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21334

Last updated 2021-01-28

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Christine Ho, MD · Centers for Disease Control and Prevention

  • Dolly Katz, PhD · Centers for Disease Control and Prevention

  • Thara Venkatappa, PhD · Centers for Disease Control and Prevention

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01622140 on ClinicalTrials.gov