Study Comparing a 2-Month Daily Drug Regimen to the Standard 4- to 6-Month Treatment for Drug-Susceptible Tuberculosis in Children Under 10 Years

What this Trial Is About

Researchers are studying treatment options for children under 10 years old who have drug-susceptible tuberculosis TB. The goal is to see if a shorter 2-month treatment regimen using isoniazid, rifapentine, pyrazinamide, and moxifloxacin is as safe and effective as the standard 4- to 6-month treatment regimen that uses isoniazid, rifampicin, pyrazinamide, and ethambutol. This study also looks at the safety of the shorter regimen in children with and without HIV. Participants will be randomly assigned to one of two treatment groups. One group will receive the standard regimen of 8 weeks of isoniazid, rifampin, pyrazinamide, and ethambutol followed by 16 or 24 weeks of isoniazid and rifampin, depending on disease severity. The other group will receive 8 weeks of daily isoniazid, rifapentine, pyrazinamide, and moxifloxacin. All drugs are given once daily based on the participants weight. During the study, children will be monitored for TB disease-free survival up to 48 weeks after starting treatment and for adverse events over 28 weeks. Researchers will also assess treatment adherence, tolerability, drug levels, and the acceptability of the treatments reported by parents or guardians. Follow-up visits and evaluations will track health outcomes and safety throughout the study period, which lasts up to about 72 weeks from entry.

Shortened Regimen for Drug-susceptible TB in Children