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



Status:Active, not recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:2/21/2019
Start Date:October 2012
End Date:September 2021

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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.


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.
We found this trial at
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sites
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Henry Blumberg, MD
Phone: 404-727-5096
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Jason Stout, MD
Phone: 919-668-0826
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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3500 Camp Bowie Boulevard
Fort Worth, Texas 76107
Principal Investigator: Thaddeus Miller, DrPH
Phone: 817-735-2242
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Baltimore, Maryland 21201
Principal Investigator: Wendy Cronin, MD
Phone: 410-767-6693
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Denver, Colorado 80204
Principal Investigator: Robert Belknap, MD
Phone: 303-602-7257
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Gainesville, Florida 32611
Principal Investigator: Michael Lauzardo, MD
Phone: 352-273-7682
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Honolulu, Hawaii 96817
Principal Investigator: Richard Brostrom, MD
Phone: 808-832-5737
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Phoenix, Arizona 85006
Principal Investigator: Renuka Khurana, MBBS
Phone: 602-506-6879
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Richmond, California 94804
Principal Investigator: Jennifer Flood, MD
Phone: 510-620-3020
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Seattle, Washington 98107
Principal Investigator: David Horne, MD
Phone: 206-744-4579
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