Window Prophylaxis for Mycobacterium Tuberculosis Infection Prevention in Children and Adolescents Living with Pulmonary Tuberculosis Patients: A Cluster-Randomized Controlled Trial

What this Trial Is About

This trial investigates whether tuberculosis preventive treatment (TPT) given during the "window period" after exposure can reduce new tuberculosis infections in children and adolescents who live with someone newly diagnosed with pulmonary tuberculosis. The study compares the rate of new infections, measured by IGRA (Interferon-Gamma Release Assay) conversion at 12 weeks, between those who receive immediate preventive treatment and those who receive standard care where treatment is only given if infection is detected. The goal is to better prevent tuberculosis infection and contribute to global elimination efforts. Participants are assigned to one of two groups. In the intervention group, all children and adolescents receive weekly doses of isoniazid and rifapentine for 12 weeks regardless of their initial IGRA test results. In the control group, only those who test positive on the IGRA test at the start receive this 12-week treatment. Those in the control group who convert to IGRA-positive during the study will also receive treatment following standard care guidelines. During the study, all participants will have IGRA testing at enrollment and again after 12 weeks to detect new infections. Researchers will monitor treatment effects and adverse events related to the 3HP regimen, as well as measure changes in immune response levels. The study lasts 12 weeks with close follow-up to assess the incidence of tuberculosis infection and the safety of the preventive treatment in this young population.

Window Prophylaxis for Pediatric Tuberculosis Prevention Trial