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Latent Tuberculosis InfectionNCT01622140

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

An observational study of Latent Tuberculosis Infection and Tuberculosis, run by Centers for Disease Control and Prevention at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Latent Tuberculosis Infection, Tuberculosis
How many people
21,334 participants
Where
10 sitesUnited States
Study dates
Oct 2012to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

  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.
  1. 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Emory University

    Atlanta, Georgia, 30303

  • Maryland Department of Public Health

    Baltimore, Maryland, 21201

  • Denver Health and Hospitals Authority

    Denver, Colorado, 80204

  • Duke University

    Durham, North Carolina, 27708

  • University of North Texas Health Science Center

    Fort Worth, Texas, 76107

  • University of Florida Board of Trustees

    Gainesville, Florida, 32611

  • Hawaii Department of Health

    Honolulu, Hawaii, 96817

  • Maricopa County Department of Public Health

    Phoenix, Arizona, 85006

  • California Department of Public Health

    Richmond, California, 94804

  • Public Health Seattle-King County

    Seattle, Washington, 98104

Other trials in United States

About this study

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.

Keywords
T-SPOT.TB, QuantiFERON-TB Gold In-Tube, Latent tuberculosis infection, Tuberculin skin test, Discordance, Predictive value, Tuberculosis disease development
Medical subject headings
Latent Tuberculosis, Tuberculosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Latent tuberculosis infection

    Measured: 3 days

  2. Tuberculosis disease at 6 months

    Measured: 6 months

  3. Tuberculosis disease at 12 months

    Measured: 12 months

  4. Tuberculosis disease at 18 months

    Measured: 18 months

  5. Tuberculosis disease at 24 months

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2012 (estimated)
  2. Study startOct 2012
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
21,334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01622140
Sponsor's protocol ID
CDC-TBESC-TO1
Status last verified
Jan 2021
First submitted
4 Jun 2012
Last updated
28 Jan 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38568690

  • 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.

    PubMed 34499863

  • 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.

    PubMed 31892518

  • 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.

    PubMed 29982223

Questions about this trial

What is this clinical trial studying?

An observational study of Latent Tuberculosis Infection and Tuberculosis, run by Centers for Disease Control and Prevention at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Latent tuberculosis infection (time frame: 3 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01622140, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.

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