RecruitingPhase 3NCT06253715

Shortened Regimen for Drug-susceptible TB in Children


Sponsor

Johns Hopkins University

Enrollment

860 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 0 DaysMax Age: 9 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ethambutol, a drug called Isoniazid, and others for people with mycobacterium tuberculosis, tuberculosis, and other related conditions. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 0 Days to 9 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIsoniazid

Once daily weight-based dose

DRUGRifampin

Once daily weight-based dose

DRUGPyrazinamide

Once daily weight-based dose

DRUGEthambutol

Once daily weight-based dose

DRUGRifapentine

Once daily weight-based dose

DRUGMoxifloxacin

Once daily weight-based dose


Locations(9)

Indian Council of Medical Research - National Institute for Research in Tuberculosis

Chennai, India

Dr. D.Y. Patil Medical College, Hospital and Research Center

Pune, India

Faculty of Medicine, Universitas Padjadjaran

Bandung, Indonesia

Instituto Nacional de Saúde (INS)

Maputo, Mozambique

Africa Health Research Institute (AHRI)

Durban, South Africa

MU-JHU Care Ltd

Kampala, Uganda

University of Zambia, School of Medicine

Lusaka, Zambia

Arthur Davison Children's Hospital

Ndola, Zambia

Harare Health and Research Consortium (HHRC)

Harare, Zimbabwe

View Full Details on ClinicalTrials.gov

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NCT06253715


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