drugset / Trial / NCT06253715

Shortened Regimen for Drug-susceptible TB in Children

NCT06253715

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-01-15
Primary completion
2027-09-30
Completion
2027-09-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ethambutol Small molecule
Subject Isoniazid Small molecule
Subject Moxifloxacin Small molecule
Comparator Rifampin Small molecule
Subject Rifapentine Small molecule
Background Pyrazinamide Small molecule