Latent Tuberculosis Infection Clinical Trial
Official title:
Comparison of Two Strategies for Therapeutic Decision-making in Tuberculosis Contact Tracing: a Standard Strategy Based on Tuberculin Skin Test (TST) Alone vs TST Combined With QuantiFERON®-TB Gold In-Tube (QFT-IT)
Hypothesis: a combined strategy of tuberculin skin test (TST) followed by QuantiFERON-TB
Gold In-Tube (QFT-IT) to confirm positivity (tuberculosis infection,in contact-tracing study
will allow avoiding unnecessary preventive treatment without increasing rates of
tuberculosis cases among contacts screened.
Aim of the study: to compare a combined strategy of the TST and the QFT-IT with TST alone
for the diagnosis of tuberculosis infection and for therapeutic decision in contact tracing
study.
Design and setting: Prospective, multicentre, comparative study in 12 hospitals in Spain.
Study population: 870 subjects, household contacts of patients with culture positive
pulmonary and/or laryngeal tuberculosis will be randomized to one of two strategies: Arm A
(standard practice), in which treatment decisions will be based on the TST result, and Arm B
(experimental), in which treatment decisions will be based on the QFT result.
Interventions: participants in arm A will undergo TST; participants in arm B will undergo
TST, and, in case of a positive result, QFT-IT as well. Participants with positive TST (arm
A) and positive QFT-IT (arm B) will be diagnosed with tuberculosis infection and will be
treated with isoniazid for 6 months. All participants will be followed for two years.
End-points of evaluation: development of tuberculosis and proportion of subjects for whom
treatment is prescribed in each arm.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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