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

Sponsor
Centers for Disease Control and Prevention (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01622140
Collaborator
(none)
21,334
10
99
2133.4
21.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    21334 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Comparison of the Tuberculin Skin Test and Interferon-Gamma Release Assays in Diagnosing Infection With Mycobacterium Tuberculosis and in Predicting Progression to Tuberculosis
    Actual Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    Dec 31, 2020
    Actual Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Latent tuberculosis infection [3 days]

    2. Tuberculosis disease at 6 months [6 months]

    3. Tuberculosis disease at 12 months [12 months]

    4. Tuberculosis disease at 18 months [18 months]

    5. Tuberculosis disease at 24 months [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maricopa County Department of Public Health Phoenix Arizona United States 85006
    2 California Department of Public Health Richmond California United States 94804
    3 Denver Health and Hospitals Authority Denver Colorado United States 80204
    4 University of Florida Board of Trustees Gainesville Florida United States 32611
    5 Emory University Atlanta Georgia United States 30303
    6 Hawaii Department of Health Honolulu Hawaii United States 96817
    7 Maryland Department of Public Health Baltimore Maryland United States 21201
    8 Duke University Durham North Carolina United States 27708
    9 University of North Texas Health Science Center Fort Worth Texas United States 76107
    10 Public Health Seattle-King County Seattle Washington United States 98104

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Centers for Disease Control and Prevention
    ClinicalTrials.gov Identifier:
    NCT01622140
    Other Study ID Numbers:
    • CDC-TBESC-TO1
    First Posted:
    Jun 18, 2012
    Last Update Posted:
    Jan 28, 2021
    Last Verified:
    Jan 1, 2021

    Study Results

    No Results Posted as of Jan 28, 2021