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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

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ClinicalTrials.gov Identifier: NCT01622140
Recruitment Status : Recruiting
First Posted : June 18, 2012
Last Update Posted : February 2, 2017
Information provided by (Responsible Party):

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
Latent Tuberculosis Infection Tuberculosis

Study Design

Study Type : Observational
Estimated Enrollment : 42647 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
Study Start Date : October 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Latent tuberculosis infection [ Time Frame: 3 days ]
  2. Tuberculosis disease at 6 months [ Time Frame: 6 months ]
  3. Tuberculosis disease at 12 months [ Time Frame: 12 months ]
  4. Tuberculosis disease at 18 months [ Time Frame: 18 months ]
  5. Tuberculosis disease at 24 months [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622140

United States, Arizona
Maricopa County Department of Public Health Recruiting
Phoenix, Arizona, United States, 85006
Contact: Renuka Khurana, MBBS    602-506-6879    renukakhurana@mail.maricopa.gov   
Contact: Angelito Bravo    602.372.2272      
Principal Investigator: Renuka Khurana, MBBS         
United States, California
California Department of Public Health Recruiting
Richmond, California, United States, 94804
Contact: Jennifer Flood, MD    510-620-3020    jennifer.flood@cdph.ca.gov   
Contact: Katya Salcedo, MPH    510.620.3042    katya.salcedo@cdph.ca.gov   
Principal Investigator: Jennifer Flood, MD         
Principal Investigator: Pennan Barry, MD         
Principal Investigator: Connie Benson, MD         
Principal Investigator: Richard Garfein, PhD         
Principal Investigator: Marisa Moore, MD         
Principal Investigator: Kathleen Moser, MD         
Principal Investigator: Lisa Pascopella, PhD         
Principal Investigator: Neha Shah, MD         
United States, Colorado
Denver Health and Hospitals Authority Recruiting
Denver, Colorado, United States, 80204
Contact: Randall Reves, MD    303-602-7257    rreves@dhha.org   
Contact: Juanita Lovato, MPH    303.602.7262    kirsten.wall@dhha.org   
Principal Investigator: Robert Belknap, MD         
Principal Investigator: Randall Reves, MD         
United States, Florida
University of Florida Board of Trustees Recruiting
Gainesville, Florida, United States, 32611
Contact: Michael Lauzardo, MD    352-273-7682    lauzam@medicine.ufl.edu   
Contact: Jody Jones, RN    954.467.4700 ext 5725    Marie_McMillan@doh.state.fl.us   
Principal Investigator: Michael Lauzardo, MD         
Principal Investigator: David Ashkin, MD         
Principal Investigator: Glenn Morris, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30303
Contact: Henry Blumberg, MD    404-727-5096    henry.m.blumberg@emory.edu   
Contact: Jane Tapia, RN    404.251.8726    jtapia@emory.edu   
Principal Investigator: Henry Blumberg, MD         
Principal Investigator: Russell Kempker, MD         
Principal Investigator: Alawode Oladele, MD         
Principal Investigator: Susan Ray, MD         
United States, Hawaii
Hawaii Department of Health Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Richard Brostrom, MD    808-832-5737    Richard.brostrom@doh.hawaii.gov   
Contact: Thara Venkatappa, PhD    808.832.5606    thara.venkatappa@doh.hawaii.gov   
Principal Investigator: Richard Brostrom, MD         
United States, Maryland
Maryland Department of Public Health Recruiting
Baltimore, Maryland, United States, 21201
Contact: Wendy Cronin, PhD    410-767-6693    croninw@dhmh.state.md.us   
Contact: Susan Dorman, MD    410.502.2717    dsusan1@jhmi.edu   
Principal Investigator: Wendy Cronin, MD         
Principal Investigator: Susan Dorman, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27708
Contact: Jason Stout, MD    919-668-0826    stout002@mc.duke.edu   
Contact: Emily J. Hecker    919.668.5142    emily.hecker@duke.edu   
Principal Investigator: Jason Stout, MD         
Principal Investigator: Timothy Sterling, MD         
Principal Investigator: Amina Ahmed, MD         
Principal Investigator: David Holland, MD         
Principal Investigator: April Pettit, MD         
United States, Texas
University of North Texas Health Science Center Recruiting
Fort Worth, Texas, United States, 76107
Contact: Thaddeus Miller, DrPH    817-735-2242    thaddeus.miller@unthsc.edu   
Contact: Erin Carlson, DrPH    817.735.2242    erin.carlson@unthsc.edu   
Principal Investigator: Thaddeus Miller, DrPH         
United States, Washington
Public Health Seattle-King County Recruiting
Seattle, Washington, United States, 98104
Contact: Masa Narita, MD    206-744-4579    masa.narita@kingcounty.gov   
Contact: Denise G Wolf, MPH    206.744.4579    denise.genarowolf@kingcounty.gov   
Principal Investigator: David Horne, MD         
Principal Investigator: Masa Narita, MD         
Sponsors and Collaborators
Centers for Disease Control and Prevention
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
More Information

Additional Information:
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01622140     History of Changes
Other Study ID Numbers: CDC-TBESC-TO1
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2016

Keywords provided by Centers for Disease Control and Prevention:
QuantiFERON-TB Gold In-Tube
Latent tuberculosis infection
Tuberculin skin test
Predictive value
Tuberculosis disease development

Additional relevant MeSH terms:
Latent Tuberculosis
Communicable Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents