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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01622140
Recruitment Status : Active, not recruiting
First Posted : June 18, 2012
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Latent Tuberculosis Infection Tuberculosis

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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 : October 2012
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine





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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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
Criteria
  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.

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


Locations
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United States, Arizona
Maricopa County Department of Public Health
Phoenix, Arizona, United States, 85006
United States, California
California Department of Public Health
Richmond, California, United States, 94804
United States, Colorado
Denver Health and Hospitals Authority
Denver, Colorado, United States, 80204
United States, Florida
University of Florida Board of Trustees
Gainesville, Florida, United States, 32611
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Hawaii
Hawaii Department of Health
Honolulu, Hawaii, United States, 96817
United States, Maryland
Maryland Department of Public Health
Baltimore, Maryland, United States, 21201
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27708
United States, Texas
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76107
United States, Washington
Public Health Seattle-King County
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Centers for Disease Control and Prevention
Investigators
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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
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01622140    
Other Study ID Numbers: CDC-TBESC-TO1
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Keywords provided by Centers for Disease Control and Prevention:
T-SPOT.TB
QuantiFERON-TB Gold In-Tube
Latent tuberculosis infection
Tuberculin skin test
Discordance
Predictive value
Tuberculosis disease development
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections