Prospective Comparison of the Tuberculin Skin Test and Interferon-Gamma Release Assays in Diagnosing Infection With Mycobacterium Tuberculosis and in Predicting Progression to Tuberculosis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01622140 |
Recruitment Status :
Completed
First Posted : June 18, 2012
Last Update Posted : January 28, 2021
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Condition or disease |
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Latent Tuberculosis Infection Tuberculosis |
Study Type : | Observational |
Actual Enrollment : | 21334 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Actual Study Start Date : | October 2012 |
Actual Primary Completion Date : | December 31, 2020 |
Actual Study Completion Date : | December 31, 2020 |

- Latent tuberculosis infection [ Time Frame: 3 days ]
- Tuberculosis disease at 6 months [ Time Frame: 6 months ]
- Tuberculosis disease at 12 months [ Time Frame: 12 months ]
- Tuberculosis disease at 18 months [ Time Frame: 18 months ]
- Tuberculosis disease at 24 months [ Time Frame: 24 months ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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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:
- Culture-positive, OR
- 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.
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622140
United States, Arizona | |
Maricopa County Department of Public Health | |
Phoenix, Arizona, United States, 85006 | |
United States, California | |
California Department of Public Health | |
Richmond, California, United States, 94804 | |
United States, Colorado | |
Denver Health and Hospitals Authority | |
Denver, Colorado, United States, 80204 | |
United States, Florida | |
University of Florida Board of Trustees | |
Gainesville, Florida, United States, 32611 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30303 | |
United States, Hawaii | |
Hawaii Department of Health | |
Honolulu, Hawaii, United States, 96817 | |
United States, Maryland | |
Maryland Department of Public Health | |
Baltimore, Maryland, United States, 21201 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27708 | |
United States, Texas | |
University of North Texas Health Science Center | |
Fort Worth, Texas, United States, 76107 | |
United States, Washington | |
Public Health Seattle-King County | |
Seattle, Washington, United States, 98104 |
Principal Investigator: | 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT01622140 |
Other Study ID Numbers: |
CDC-TBESC-TO1 |
First Posted: | June 18, 2012 Key Record Dates |
Last Update Posted: | January 28, 2021 |
Last Verified: | January 2021 |
T-SPOT.TB QuantiFERON-TB Gold In-Tube Latent tuberculosis infection Tuberculin skin test |
Discordance Predictive value Tuberculosis disease development |
Infections Communicable Diseases Tuberculosis Latent Tuberculosis Disease Attributes Pathologic Processes |
Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Latent Infection |