TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts
NCT06022146 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3520
Last updated 2025-12-22
Summary
This is a prospective, multi-center, open-label, cluster randomized controlled clinical trial conducted in school settings to estimate the non-inferiority effect of 1H3P3 compared with 3HR.
Conditions
- Tuberculosis
- Latent Tuberculosis
Interventions
- DRUG
-
isoniazid and rifapentine
12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for 4 weeks
- DRUG
-
Rifampin and Isoniazid
3HR regimen of isoniazid and rifampicin once daily for three months
Sponsors & Collaborators
-
Huashan Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-01
- Primary Completion
- 2026-09-01
- Completion
- 2026-09-01
Countries
- China
Study Locations
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