Latent Tuberculosis Infection, Tuberculosis
Conditions
Keywords
T-SPOT.TB, QuantiFERON-TB Gold In-Tube, Latent tuberculosis infection, Tuberculin skin test, Discordance, Predictive value, Tuberculosis disease development
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.
Interventions
None listed
Sponsors
Centers for Disease Control and Prevention
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Latent tuberculosis infection | 3 days |
| Tuberculosis disease at 6 months | 6 months |
| Tuberculosis disease at 12 months | 12 months |
| Tuberculosis disease at 18 months | 18 months |
| Tuberculosis disease at 24 months | 24 months |
Countries
United States
Outcome results
None listed