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

NCT ID: NCT01622140

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21334 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Latent Tuberculosis Infection Tuberculosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Exclusion Criteria

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Ho, MD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Dolly Katz, PhD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Thara Venkatappa, PhD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Locations

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Maricopa County Department of Public Health

Phoenix, Arizona, United States

Site Status

California Department of Public Health

Richmond, California, United States

Site Status

Denver Health and Hospitals Authority

Denver, Colorado, United States

Site Status

University of Florida Board of Trustees

Gainesville, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Hawaii Department of Health

Honolulu, Hawaii, United States

Site Status

Maryland Department of Public Health

Baltimore, Maryland, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

University of North Texas Health Science Center

Fort Worth, Texas, United States

Site Status

Public Health Seattle-King County

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38568690 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34499863 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31892518 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29982223 (View on PubMed)

Other Identifiers

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CDC-TBESC-TO1

Identifier Type: -

Identifier Source: org_study_id

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