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

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622140
• Other study ID #: CDC-TBESC-TO1
• Status: Completed
• Start date: October 2012
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21334
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Latent Tuberculosis
• Latent Tuberculosis Infection
• Tuberculosis

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Maryland Department of Public Health	Baltimore	Maryland
United States	Denver Health and Hospitals Authority	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	University of North Texas Health Science Center	Fort Worth	Texas
United States	University of Florida Board of Trustees	Gainesville	Florida
United States	Hawaii Department of Health	Honolulu	Hawaii
United States	Maricopa County Department of Public Health	Phoenix	Arizona
United States	California Department of Public Health	Richmond	California
United States	Public Health Seattle-King County	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Latent tuberculosis infection		3 days
Primary	Tuberculosis disease at 6 months		6 months
Primary	Tuberculosis disease at 12 months		12 months
Primary	Tuberculosis disease at 18 months		18 months
Primary	Tuberculosis disease at 24 months		24 months

External Links

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