Prospective Comparison of the Tuberculin Skin Test and Interferon-Gamma Release Assays in Diagnosing Infection With Mycobacterium Tuberculosis and in Predicting Progression to Tuberculosis
Information source: Centers for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Latent Tuberculosis Infection; Tuberculosis Disease
Phase: N/A
Status: Not yet recruiting
Sponsored by: Centers for Disease Control and Prevention Official(s) and/or principal investigator(s): Denise Garrett, MD, Principal Investigator, Affiliation: Centers for Disease Control and Prevention Dolly Katz, PhD, Principal Investigator, Affiliation: Centers for Disease Control and Prevention Sekai Chideya, MD, Principal Investigator, Affiliation: Centers for Disease Control and Prevention
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.
Clinical Details
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 design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Latent tuberculosis infectionTuberculosis disease at 6 months Tuberculosis disease at 12 months Tuberculosis disease at 18 months Tuberculosis disease at 24 months
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Maricopa County Department of Public Health, Phoenix, Arizona 85006, United States
California Department of Public Health, Richmond, California 94804, United States; Not yet recruiting Jennifer Flood, MD, Phone: 510-620-3020, Email: jennifer.flood@cdph.ca.gov Katya Salcedo, MPH, Phone: 510.620.3042, Email: katya.salcedo@cdph.ca.gov 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, Principal Investigator
Denver Health and Hospitals Authority, Denver, Colorado 80204, United States; Not yet recruiting Randall Reves, MD, Phone: 303-602-7257, Email: rreves@dhha.org Kirsten Wall, MHS, Phone: 303.602.7262, Email: kirsten.wall@dhha.org Robert Belknap, MD, Principal Investigator Randall Reves, MD, Principal Investigator
University of Florida Board of Trustees, Gainesville, Florida 32611, United States
Emory University, Atlanta, Georgia 30303, United States; Not yet recruiting Henry Blumberg, MD, Phone: 404-727-5096, Email: henry.m.blumberg@emory.edu Jane Tapia, RN, Phone: 404.251.8726, Email: jtapia@emory.edu Henry Blumberg, MD, Principal Investigator Russell Kempker, MD, Principal Investigator Alawode Oladele, MD, Principal Investigator Susan Ray, MD, Principal Investigator
Hawaii Department of Health, Honolulu, Hawaii 96817, United States; Not yet recruiting Richard Brostrom, MD, Phone: 808-832-5737, Email: Richard.brostrom@doh.hawaii.gov Thara Venkatappa, PhD, Phone: 808.832.5606, Email: thara.venkatappa@doh.hawaii.gov Richard Brostrom, MD, Principal Investigator
Maryland Department of Public Health, Baltimore, Maryland 21201, United States; Not yet recruiting Wendy Cronin, PhD, Phone: 410-767-6693, Email: croninw@dhmh.state.md.us Susan Dorman, MD, Phone: 410.502.2717, Email: dsusan1@jhmi.edu Wendy Cronin, MD, Principal Investigator Susan Dorman, MD, Principal Investigator
Duke University, Durham, North Carolina 27708, United States; Not yet recruiting Jason Stout, MD, Phone: 919-668-0826, Email: stout002@mc.duke.edu Emily J. Hecker, Phone: 919.668.5142, Email: emily.hecker@duke.edu Jason Stout, MD, Principal Investigator Timothy Sterling, MD, Principal Investigator Amina Ahmed, MD, Principal Investigator David Holland, MD, Principal Investigator April Pettit, MD, Principal Investigator
University of North Texas Health Science Center, Fort Worth, Texas 76107, United States
Public Health Seattle-King County, Seattle, Washington 98104, United States
Additional Information
Starting date: October 2012
Last updated: June 14, 2012
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