BRIGHT-Child TB: Short-Course Treatment for Non-Severe Pulmonary Tuberculosis in Children
Condition(s) studied
Investigational drug(s) / intervention(s)
4-month FDC-based regimen: 4-month fixed-dose combination (FDC) regimen
3-month BDCZ regimen: 3-month bedaquiline, delamanid, contezolid, and pyrazinamide (BDCZ) regimen
Standard 6-month treatment regimen: Standard 6-month treatment regimen, namely 2HRZ(E)/HR.
Study summary
The goal of this Phase II, multicenter, open-label, randomized controlled trial is to evaluate the efficacy and safety of short-course treatment regimens for children with non-severe, drug-susceptible pulmonary tuberculosis.
The main questions it aims to answer are:
* Do the 3-month bedaquiline, delamanid, contezolid, and pyrazinamide regimen (BDCZ) and the 4-month fixed-dose combination (FDC) regimen provide effective treatment, as measured by tuberculosis-free survival at 12 months after treatment initiation?
* What are the safety profiles of the two short-course regimens, as measured by the incidence of grade 3 or higher adverse events?
* How do the short-course regimens compare with the standard 6-month treatment regimen in terms of treatment success, treatment failure, recurrence, and tuberculosis-free survival during follow-up?
Researchers will compare the 3-month BDCZ regimen and the 4-month FDC regimen with the standard 6-month treatment regimen to evaluate their efficacy and safety in children with non-severe, drug-susceptible pulmonary tuberculosis.
Participants will be randomly assigned to one of three treatment groups and will receive the allocated regimen. They will undergo clinical assessments and safety monitoring during treatment, with follow-up to assess treatment outcomes, tuberculosis recurrence, and tuberculosis-free survival at 12, 18, and 24 months after treatment initiation.
Eligibility
Primary outcome measure(s)
- Tuberculosis-free survival at 12 months — 12 months after treatment initiation
Proportion of participants alive and free of tuberculosis at 12 months after treatment initiation. - Incidence of grade 3 or higher adverse events — From treatment initiation to the end of the assigned treatment regimen (3, 4, or 6 months)
Proportion of participants experiencing one or more grade 3 or higher adverse events during treatment.
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province | Fuzhou | Fujian | Recruiting |
| Guangzhou Chest Hospital | Guangzhou | Guangdong | Recruiting |
| Guiyang Public Health Clinical Center | Guiyang | Guizhou | Recruiting |
| Third People's Hospital of Liupanshui | Liupanshui | Guizhou | Recruiting |
| Zunyi Infectious Diseases Hospital | Zunyi | Guizhou | Recruiting |
| The Fifth People's Hospital of Suzhou | Suzhou | Jiangsu | Recruiting |
| Ganzhou Fifth People's Hospital | Ganzhou | Jiangxi | Recruiting |
| The Fourth People's Hospital of Qinghai Province | Xining | Qinghai | Recruiting |
| Shandong Public Health Clinical Center | Jinan | Shandong | Recruiting |
| Huashan Hospital | Shanghai | Shanghai Municipality | Recruiting |
| The First Affiliated Hospital of Shihezi University | Shihezi | Xinjiang Uygur Autonomous Region | Recruiting |
| Hangzhou Red Cross Hospital | Hangzhou | Zhejiang | Recruiting |
| The Children's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | Recruiting |
More Huashan Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07893444 on ClinicalTrials.gov ↗ ← All trials in China