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

NCT01622140 | Completed

• 1 other identifier: CDC-TBESC-TO1
• Study Type: observational
• Target: 21,334
• Locations: 1 country
• Sites: 10

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.

Conditions

Latent Tuberculosis Infection; Tuberculosis

Keywords

T-SPOT.TB; QuantiFERON-TB Gold In-Tube; Latent tuberculosis infection; Tuberculin skin test; Discordance; Predictive value; Tuberculosis disease development

Outcome Measures

Primary Outcomes (5)

• Latent tuberculosis infection

  3 days

• Tuberculosis disease at 6 months

  6 months

• Tuberculosis disease at 12 months

  12 months

• Tuberculosis disease at 18 months

  18 months

• Tuberculosis disease at 24 months

  24 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may not qualify if:

• People with known current active tuberculosis.
• People with a previous anaphylactic reaction to tuberculin.
• Persons currently being treated for latent tuberculosis infection.
• 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.
• Foster children.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead

Study Sites (10)

Maricopa County Department of Public Health

Phoenix, Arizona, 85006, United States

Location

California Department of Public Health

Richmond, California, 94804, United States

Location

Denver Health and Hospitals Authority

Denver, Colorado, 80204, United States

Location

University of Florida Board of Trustees

Gainesville, Florida, 32611, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Hawaii Department of Health

Honolulu, Hawaii, 96817, United States

Location

Maryland Department of Public Health

Baltimore, Maryland, 21201, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

Public Health Seattle-King County

Seattle, Washington, 98104, United States

Location

Related Publications (4)

• Ayers T, Hill AN, Raykin J, Mohanty S, Belknap RW, Brostrom R, Khurana R, Lauzardo M, Miller TL, Narita M, Pettit AC, Pyan A, Salcedo KL, Polony A, Flood J; CDC Tuberculosis Epidemiologic Studies Consortium. Comparison of Tuberculin Skin Testing and Interferon-gamma Release Assays in Predicting Tuberculosis Disease. JAMA Netw Open. 2024 Apr 1;7(4):e244769. doi: 10.1001/jamanetworkopen.2024.4769.

  PMID: 38568690 DERIVED

• Ho CS, Feng PI, Narita M, Stout JE, Chen M, Pascopella L, Garfein R, Reves R, Katz DJ; Tuberculosis Epidemiologic Studies Consortium. Comparison of three tests for latent tuberculosis infection in high-risk people in the USA: an observational cohort study. Lancet Infect Dis. 2022 Jan;22(1):85-96. doi: 10.1016/S1473-3099(21)00145-6. Epub 2021 Sep 6.

  PMID: 34499863 DERIVED

• Ahmed A, Feng PI, Gaensbauer JT, Reves RR, Khurana R, Salcedo K, Punnoose R, Katz DJ; TUBERCULOSIS EPIDEMIOLOGIC STUDIES CONSORTIUM. Interferon-gamma Release Assays in Children <15 Years of Age. Pediatrics. 2020 Jan;145(1):e20191930. doi: 10.1542/peds.2019-1930.

  PMID: 31892518 DERIVED

• Stout JE, Wu Y, Ho CS, Pettit AC, Feng PJ, Katz DJ, Ghosh S, Venkatappa T, Luo R; Tuberculosis Epidemiologic Studies Consortium. Evaluating latent tuberculosis infection diagnostics using latent class analysis. Thorax. 2018 Nov;73(11):1062-1070. doi: 10.1136/thoraxjnl-2018-211715. Epub 2018 Jul 7.

  PMID: 29982223 DERIVED

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 18, 2012
• Study Start: October 1, 2012
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

US (10)