Shortened Regimen for Drug-susceptible TB in Children

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• United States Agency for International Development (USAID)

  collaborator FED

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Nicole Salazar-Austin, MD, ScM · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Days

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-15

Primary Completion

2027-09-30

Completion

2027-09-30

Countries

• India
• Indonesia
• Mozambique
• South Africa
• Uganda
• Zambia
• Zimbabwe

Study Locations