Clinical trial NCT01622140: Prospective Comparison of the Tuberculin Skin Test and Interferon-Gamma Release Assays in Diagnosing Infection With Mycobacterium Tuberculosis and in Predicting Progression to Tuberculosis
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 type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2012-06-18
Enrollment: 21334
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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.

Primary outcomes:
measure: Latent tuberculosis infection
timeFrame: 3 days
measure: Tuberculosis disease at 6 months
timeFrame: 6 months
measure: Tuberculosis disease at 12 months
timeFrame: 12 months
measure: Tuberculosis disease at 18 months
timeFrame: 18 months
measure: Tuberculosis disease at 24 months
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa County Department of Public Health
state: Arizona
city: Richmond
country: United States
facility: California Department of Public Health
state: California
city: Denver
country: United States
facility: Denver Health and Hospitals Authority
state: Colorado
city: Gainesville
country: United States
facility: University of Florida Board of Trustees
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Department of Health
state: Hawaii
city: Baltimore
country: United States
facility: Maryland Department of Public Health
state: Maryland
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center
state: Texas
city: Seattle
country: United States
facility: Public Health Seattle-King County
state: Washington
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Christine Ho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Dolly Katz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Thara Venkatappa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.