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

January 27, 2021 updated by: Centers for Disease Control and Prevention
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

21334

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Maricopa County Department of Public Health
    • California
      • Richmond, California, United States, 94804
        • California Department of Public Health
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health and Hospitals Authority
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida Board of Trustees
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Department of Health
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Maryland Department of Public Health
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke University
    • Texas
      • Fort Worth, Texas, United States, 76107
        • University of North Texas Health Science Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Public Health Seattle-King County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals at high risk for latent tuberculosis infection or at high risk for progression to tuberculosis from health clinics, hospitals, or health departments at the 10 Tuberculosis Epidemiologic Studies Consortium sites within the United States: California Department of Public Health, Denver Health and Hospital Authority, Duke University, Emory University, Hawaii Department of Health, Maricopa County Department of Public Health, Maryland Department of Public Health, Public Health Seattle-King County, University of Florida Board of Trustees, and University of North Texas Health Science Center

Description

  1. Study participants must be at high risk for latent tuberculosis infection or at high risk for progression to tuberculosis disease, including being a:

    • Close contact of a person with pulmonary tuberculosis who is part of a current contact investigation and the index/source case meets the following criteria:

    1. Culture-positive, OR
    2. Culture-negative and smear positive and nucleic acid amplification test-positive.

    Participants may be enrolled before the culture results for the index/source case are available. If the criteria described above are not met once results are available, the participant will be terminated from the study and any collected data will be immediately destroyed.

    A close contact is defined as spending 15 or more hours over a week's period in a shared airspace with a person with active pulmonary tuberculosis while that person was presumed to be infectious.

    • Foreign-born person from a high risk country.
    • Foreign-born person from a medium risk country who moved to the United States within the past 5 years.
    • Person who has spent at least 30 days in total in a high risk country within the last 5 years.
    • Person belonging to a population with a prevalence of latent tuberculosis infection ≥ 25% as demonstrated by local surveys. These populations will vary by site; examples include Mexican immigrants in San Diego, California or homeless drug users in Baltimore, Maryland.
    • HIV-positive person.
  2. Study participants (or a parent/guardian, if applicable) must be willing and able to provide informed consent.

4.2 Subject Exclusion Criteria

Subjects meeting any of the exclusion criteria will be excluded from study enrollment.

  1. People with known current active tuberculosis.
  2. People with a previous anaphylactic reaction to tuberculin.
  3. Persons currently being treated for latent tuberculosis infection.
  4. Persons anticipating or scheduled to permanently leave the United States (e.g., tourists, visiting scholars, exchange students) in less than 2 years from the time of proposed study enrollment.
  5. Foster children.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Latent tuberculosis infection
Time Frame: 3 days
3 days
Tuberculosis disease at 6 months
Time Frame: 6 months
6 months
Tuberculosis disease at 12 months
Time Frame: 12 months
12 months
Tuberculosis disease at 18 months
Time Frame: 18 months
18 months
Tuberculosis disease at 24 months
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Christine Ho, MD, Centers for Disease Control and Prevention
  • Principal Investigator: Dolly Katz, PhD, Centers for Disease Control and Prevention
  • Principal Investigator: Thara Venkatappa, PhD, Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (Estimate)

June 18, 2012

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-TBESC-TO1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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