Shortened Regimen for Drug-susceptible TB in Children

While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.

NCT Number	NCT06253715
Lead Sponsor	Johns Hopkins University Collaborators: United States Agency for International Development (USAID)
Conditions	Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Lymph Node, Mycobacterium Tuberculosis
Enrollment	860 participants
Start Date	2025-01-15
Primary Completion	2027-09-30 (estimated)
Study Completion	2027-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-24