NCT06253715

Shortened Regimen for Drug-susceptible TB in Children

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 860 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 0 Days – 9 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In previously untreated individuals with presumed drug-susceptible pulmonary and or peripheral lymph node TB treated with eight weeks of rifapentine, isoniazid, pyrazinamide and moxifloxacin (2HPZM), all given daily throughout, the proportion of participants who experience absence of cure (unsuccessful outcome) will not be inferior to that observed in participants who are treated with the standard regimen (eight weeks of rifampin, isoniazid, pyrazinamide, with or without ethambutol followed by 8 to 16 weeks of rifampin plus isoniazid depending on disease severity) all given daily throughout.

Conditions

• Tuberculosis
• Tuberculosis, Pulmonary
• Tuberculosis, Lymph Node
• Mycobacterium Tuberculosis

Interventions

Type	Name	Description
DRUG	Isoniazid	Once daily weight-based dose
DRUG	Rifampin	Once daily weight-based dose
DRUG	Pyrazinamide	Once daily weight-based dose
DRUG	Ethambutol	Once daily weight-based dose
DRUG	Rifapentine	Once daily weight-based dose
DRUG	Moxifloxacin	Once daily weight-based dose

Timeline

• Start date: 2025-01-15
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2024-02-12
• Last updated: 2026-04-02

Locations

9 sites across 7 countries: India, Indonesia, Mozambique, South Africa, Uganda, Zambia, Zimbabwe