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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

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 infection

Tuberculosis 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

Page last updated: August 23, 2015

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