Actively Recruiting
Shortened Regimen for Drug-susceptible TB in Children
Led by Johns Hopkins University · Updated on 2026-04-02
860
Participants Needed
9
Research Sites
141 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
U
United States Agency for International Development (USAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Shortened Regimen for Drug-susceptible TB in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or guardian willing and able to provide written informed consent; assent from child if applicable
- Child under 10 years of age at entry
- Child weighs 3 kilograms or more at entry
- Diagnosed with pulmonary (including pleural effusion) and/or lymph node TB, with or without bacteriologic confirmation
- Clinician plans to treat with standard first-line drug-susceptible TB regimen
- Known HIV status or HIV testing in progress
- Normal or mild (Grade 1 or 2) lab test results within 14 days of entry for ALT, total bilirubin, potassium, hemoglobin, platelet count, and eGFR
- For children with HIV: on or able to switch to dolutegravir-based ART at or before entry, or planned initiation by study Week 4
- For participants post-menarche or sexually active: negative pregnancy test within 7 days of entry
- For participants sexually active and able to conceive: agree to use non-hormonal contraception or abstain from heterosexual intercourse during treatment and 30 days after
- Intends to stay in study area or willing to be followed beyond if applicable
You will not qualify if you...
- TB involving central nervous system, bones/joints, miliary, pericardial, gastrointestinal, or renal sites
- Premature infant born before 37 weeks gestation and less than 3 months old at entry
- Known allergy or intolerance to study drugs or related drugs
- Use of prohibited medications within 3 days before entry or planned use within 6 months
- Unable to take oral medications
- Known history of prolonged QT syndrome not caused by electrolyte problems
- More than 10 days of TB treatment in past 6 months
- Known or suspected resistance to isoniazid, rifampin, pyrazinamide, ethambutol, or fluoroquinolones
- Exposure to infectious adult with drug-resistant TB
- Any other medical condition that could make participation unsafe or interfere with study
- Previously enrolled in this study
- Later exclusions include detection of drug-resistant TB from samples around entry or definitive alternative diagnosis ending TB treatment early
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Indian Council of Medical Research - National Institute for Research in Tuberculosis
Chennai, India
Not Yet Recruiting
2
Dr. D.Y. Patil Medical College, Hospital and Research Center
Pune, India
Not Yet Recruiting
3
Faculty of Medicine, Universitas Padjadjaran
Bandung, Indonesia
Actively Recruiting
4
Instituto Nacional de Saúde (INS)
Maputo, Mozambique
Not Yet Recruiting
5
Africa Health Research Institute (AHRI)
Durban, South Africa
Not Yet Recruiting
6
MU-JHU Care Ltd
Kampala, Uganda
Actively Recruiting
7
University of Zambia, School of Medicine
Lusaka, Zambia
Actively Recruiting
8
Arthur Davison Children's Hospital
Ndola, Zambia
Not Yet Recruiting
9
Harare Health and Research Consortium (HHRC)
Harare, Zimbabwe
Actively Recruiting
Research Team
K
Kisten Nolan, MPH, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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