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 recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Centers for Disease Control and Prevention.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01622140
First received: June 4, 2012
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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
Latent Tuberculosis Infection
Tuberculosis Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Latent tuberculosis infection [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Tuberculosis disease at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Tuberculosis disease at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Tuberculosis disease at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Tuberculosis disease at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 42647
Study Start Date: October 2012
  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622140

Locations
United States, Arizona
Maricopa County Department of Public Health
Phoenix, Arizona, United States, 85006
United States, California
California Department of Public Health Not yet 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 Not yet recruiting
Denver, Colorado, United States, 80204
Contact: Randall Reves, MD    303-602-7257    rreves@dhha.org   
Contact: Kirsten Wall, MHS    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
Gainesville, Florida, United States, 32611
United States, Georgia
Emory University Not yet 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 Not yet 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 Not yet 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 Not yet 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
Fort Worth, Texas, United States, 76107
United States, Washington
Public Health Seattle-King County
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Investigators
Principal Investigator: Denise Garrett, MD Centers for Disease Control and Prevention
Principal Investigator: Dolly Katz, PhD Centers for Disease Control and Prevention
Principal Investigator: Sekai Chideya, MD Centers for Disease Control and Prevention
  More Information

Additional Information:
No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01622140     History of Changes
Other Study ID Numbers: CDC-TBESC-TO1
Study First Received: June 4, 2012
Last Updated: June 14, 2012
Health Authority: United States: Federal Government

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:
Communicable Diseases
Infection
Latent Tuberculosis
Mycobacterium Infections
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Interferon-gamma
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014