TuberculosisPhase 2NCT07893444
BRIGHT-Child TB: Short-Course Treatment for Non-Severe Pulmonary Tuberculosis in Children
A Phase 2 study testing 4-month FDC-based regimen, 3-month BDCZ regimen and Standard 6-month treatment regimen in people with Tuberculosis, run by Huashan Hospital at 13 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- 4-month FDC-based regimen, 3-month BDCZ regimen and Standard 6-month treatment regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 13 sitesChina
- Study dates
- 8 Jul 2026to 30 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 3 months to 18 years.
- Body weight of at least 3 kg.
- Diagnosis of pulmonary TB according to the Chinese health industry standard WS 288-2017, Diagnosis of Tuberculosis, meeting the criteria for clinically diagnosed or bacteriologically confirmed tuberculosis.
- Symptomatic, non-severe tuberculosis, meeting the following criteria: Chest imaging findings consistent with pulmonary tuberculosis, with the investigator determining that the child is eligible for treatment of non-severe tuberculosis, and no cavitation or signs of miliary tuberculosis; Uncomplicated tuberculous pleurisy, without empyema, pneumothorax, or bronchopleural fistula; Intrathoracic lymph node tuberculosis without airway obstruction, or peripheral lymph node tuberculosis; Low bacillary burden, defined as a negative acid-fast bacilli (AFB) smear result from a respiratory specimen. A positive or negative Xpert MTB/RIF result is permitted. A negative Xpert MTB/RIF result may be accepted as an alternative to a negative smear result. Respiratory specimen culture results may be positive or negative.
- No previous anti-tuberculosis treatment, or previous treatment resulting in successful cure, with treatment having been completed more than 2 years before enrollment.
- Willingness to undergo HIV antibody testing.
Show all 9Show fewer
- Willingness and ability to complete the assigned treatment and follow-up visits after treatment discontinuation.
- Written informed consent obtained from a parent or legal guardian.
- Residence and follow-up arrangements that allow the participant to complete the follow-up period within the study recruitment area.
Who cannot join
- Positive AFB smear result from a respiratory specimen or gastric aspirate. A positive smear result from a lymph node specimen is permitted.
- Age younger than 3 months.
- One or more of the following forms of TB: miliary TB, tuberculous meningitis, osteoarticular TB, abdominal or gastrointestinal TB, genitourinary TB, or reproductive system TB.
- A non-tuberculosis condition that may affect treatment response or outcome assessment, including hepatic, renal, or cardiac disease; a corrected QT interval using Fridericia's formula (QTcF) greater than 450 ms in males or 470 ms in females; a condition requiring long-term immunosuppressive therapy; primary immunodeficiency; peripheral neuropathy; or cavitary disease.
- Contraindication to any anti-tuberculosis drug included in the assigned treatment regimen.
- Close contact within 6 months before enrollment with an adult diagnosed with drug-resistant tuberculosis, including tuberculosis with resistance to a single drug.
Show all 9Show fewer
- Diagnosis of drug-resistant TB before enrollment.
- Critical illness.
- Any other condition that, in the investigator's judgment, makes the child unsuitable for participation in the study.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province
Fuzhou, Fujian
Yan Ruan
Yan Ruan
- Recruiting
Ganzhou Fifth People's Hospital
Ganzhou, Jiangxi
Pinghua Peng
Pinghua Peng
- Recruiting
Guangzhou Chest Hospital
Guangzhou, Guangdong
Shaomei Huang
Shaomei Huang
- Recruiting
Guiyang Public Health Clinical Center
Guiyang, Guizhou
Shusong Ruan
Shusong Ruan
- Recruiting
Hangzhou Red Cross Hospital
Hangzhou, Zhejiang
Yuanyuan Chen
Yuanyuan Chen
- Recruiting
The Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Lisu Huang
Lisu Huang
- Recruiting
Shandong Public Health Clinical Center
Jinan, Shandong
Mingxia Sun
Mingxia Sun
- Recruiting
Third People's Hospital of Liupanshui
Liupanshui, Guizhou
Yiming Li, 3412426@qq.com
Yiming Li
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality
Tao Li, 13816829726, litaokc@vip.163.com
Wenhong Zhang
- Recruiting
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang Uygur Autonomous Region
Songsong Xie
Songsong Xie
- Recruiting
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu
Xin Yu
Xin Yu
- Recruiting
The Fourth People's Hospital of Qinghai Province
Xining, Qinghai
Hongmei Zu
Hongmei Zu
- Recruiting
Zunyi Infectious Diseases Hospital
Zunyi, Guizhou
Youqian Chen
Youqian Chen
About this study
Official title: A Multicenter, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of a Short-Course Treatment Regimen for Non-Severe Pulmonary Tuberculosis in Children (BRIGHT-Child TB)
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:
Read more
- 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.
Read the detailed description
Tuberculosis remains an important cause of morbidity in children. Shortening treatment duration while maintaining efficacy and safety is a key priority in the management of childhood tuberculosis. Evidence from previous studies has demonstrated that a 4-month treatment regimen can be effective for children with non-severe, drug-susceptible pulmonary tuberculosis. However, the implementation of short-course treatment in China remains challenging, partly because of limited availability of child-friendly formulations that support accurate dosing and treatment adherence.
Newer anti-tuberculosis drugs and combinations with potent bactericidal activity offer opportunities to further shorten treatment duration. However, clinical evidence supporting the use of these regimens in children with drug-susceptible tuberculosis remains limited. In addition, child-friendly fixed-dose combination (FDC) formulations may facilitate the implementation of short-course treatment by simplifying drug administration and improving dosing accuracy and adherence.
This Phase II, multicenter, open-label, randomized controlled trial will evaluate the efficacy and safety of two short-course treatment regimens in children with non-severe, drug-susceptible pulmonary tuberculosis. The study includes three treatment groups: a 3-month regimen containing bedaquiline, delamanid, contezolid, and pyrazinamide (BDCZ); a 4-month FDC-based regimen; and the standard 6-month treatment regimen as the control.
The study will assess whether the short-course regimens provide favorable treatment outcomes while maintaining an acceptable safety profile. Efficacy assessments will include tuberculosis-free survival, treatment success, treatment failure, and tuberculosis recurrence. Safety assessments will focus on adverse events, including grade 3 or higher adverse events.
Participants will receive the treatment assigned through randomization and will undergo clinical assessments and safety monitoring during treatment. Follow-up after treatment initiation will evaluate longer-term treatment outcomes, including tuberculosis recurrence and tuberculosis-free survival.
The findings of this study will provide clinical evidence on the potential use of shorter treatment regimens for children with non-severe, drug-susceptible pulmonary tuberculosis and may inform the development and implementation of more child-friendly treatment strategies.
- Conditions
- Tuberculosis
- Being tested
- 4-month FDC-based regimen, 3-month BDCZ regimen, Standard 6-month treatment regimen
- Keywords
- children, pulmonary TB, non-severe, short-course treatment
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-month FDC-based regimenDrug
Also called 4FDC
4-month fixed-dose combination (FDC) regimen
3-month BDCZ regimenDrug
Also called 3BDCZ
3-month bedaquiline, delamanid, contezolid, and pyrazinamide (BDCZ) regimen
Standard 6-month treatment regimenDrug
Also called 2HRZ(E)/4HR
Standard 6-month treatment regimen, namely 2HRZ(E)/HR.
| Study group | Role | What they receive |
|---|---|---|
| 4FDC | Experimental | Not described Receives: Drug: 4-month FDC-based regimen |
| 3BDCZ | Experimental | Not described Receives: Drug: 3-month BDCZ regimen |
| 2HRZ(E)/4HR | Active comparator | Not described Receives: Drug: Standard 6-month treatment regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tuberculosis-free survival at 12 months
Proportion of participants alive and free of tuberculosis at 12 months after treatment initiation.
Measured: 12 months after treatment initiation
Incidence of grade 3 or higher adverse events
Proportion of participants experiencing one or more grade 3 or higher adverse events during treatment.
Measured: From treatment initiation to the end of the assigned treatment regimen (3, 4, or 6 months)
Secondary outcomes (5)
Tuberculosis recurrence at 12 months
Proportion of participants who experience tuberculosis recurrence within 12 months after treatment initiation.
Measured: 12 months after treatment initiation
Treatment success and treatment failure at the end of treatment
Proportions of participants classified as having treatment success or treatment failure according to the protocol-defined physician assessment at the end of the assigned treatment regimen.
Measured: At the end of the assigned treatment regimen (3, 4, or 6 months)
Tuberculosis-free survival at 18 and 24 months
Proportion of participants alive and free of tuberculosis at 18 and 24 months after treatment initiation.
Measured: 18 and 24 months after treatment initiation
Tuberculosis recurrence at 18 and 24 months
Proportion of participants who experience tuberculosis recurrence within 18 and 24 months after treatment initiation.
Measured: 18 and 24 months after treatment initiation
Clinical outcomes at the end of follow-up
Proportions of participants with favorable and unfavorable clinical outcomes at the end of follow-up, as defined in the study protocol.
Measured: 24 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start8 Jul 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893444
- Sponsor's protocol ID
- KY2025-1518
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of a Short-Course Treatment Regimen for Non-Severe Pulmonary Tuberculosis in Children (BRIGHT-Child TB)
- ClinicalTrials.gov ID
- NCT07893444
- Acronym / sponsor ID
- KY2025-1518
- Conditions
- Tuberculosis
- Keywords
- children, pulmonary TB, non-severe, short-course treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tuberculosis remains an important cause of morbidity in children. Shortening treatment duration while maintaining efficacy and safety is a key priority in the management of childhood tuberculosis. Evidence from previous studies has demonstrated that a 4-month treatment regimen can be effective for children with non-severe, drug-susceptible pulmonary tuberculosis. However, the implementation of short-course treatment in China remains challenging, partly because of limited availability of child-friendly formulations that support accurate dosing and treatment adherence.
Newer anti-tuberculosis drugs and combinations with potent bactericidal activity offer opportunities to further shorten treatment duration. However, clinical evidence supporting the use of these regimens in children with drug-susceptible tuberculosis remains limited. In addition, child-friendly fixed-dose combination (FDC) formulations may facilitate the implementation of short-course treatment by simplifying drug administration and improving dosing accuracy and adherence.
This Phase II, multicenter, open-label, randomized controlled trial will evaluate the efficacy and safety of two short-course treatment regimens in children with non-severe, drug-susceptible pulmonary tuberculosis. The study includes three treatment groups: a 3-month regimen containing bedaquiline, delamanid, contezolid, and pyrazinamide (BDCZ); a 4-month FDC-based regimen; and the standard 6-month treatment regimen as the control.
The study will assess whether the short-course regimens provide favorable treatment outcomes while maintaining an acceptable safety profile. Efficacy assessments will include tuberculosis-free survival, treatment success, treatment failure, and tuberculosis recurrence. Safety assessments will focus on adverse events, including grade 3 or higher adverse events.
Participants will receive the treatment assigned through randomization and will undergo clinical assessments and safety monitoring during treatment. Follow-up after treatment initiation will evaluate longer-term treatment outcomes, including tuberculosis recurrence and tuberculosis-free survival.
The findings of this study will provide clinical evidence on the potential use of shorter treatment regimens for children with non-severe, drug-susceptible pulmonary tuberculosis and may inform the development and implementation of more child-friendly treatment strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4FDC | Experimental | Drug: 4-month FDC-based regimen |
| 3BDCZ | Experimental | Drug: 3-month BDCZ regimen |
| 2HRZ(E)/4HR | Active comparator | Drug: Standard 6-month treatment regimen |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Children aged 3 months to 18 years.
- Body weight of at least 3 kg.
- Diagnosis of pulmonary TB according to the Chinese health industry standard WS 288-2017, Diagnosis of Tuberculosis, meeting the criteria for clinically diagnosed or bacteriologically confirmed tuberculosis.
- Symptomatic, non-severe tuberculosis, meeting the following criteria: Chest imaging findings consistent with pulmonary tuberculosis, with the investigator determining that the child is eligible for treatment of non-severe tuberculosis, and no cavitation or signs of miliary tuberculosis; Uncomplicated tuberculous pleurisy, without empyema, pneumothorax, or bronchopleural fistula; Intrathoracic lymph node tuberculosis without airway obstruction, or peripheral lymph node tuberculosis; Low bacillary burden, defined as a negative acid-fast bacilli (AFB) smear result from a respiratory specimen. A positive or negative Xpert MTB/RIF result is permitted. A negative Xpert MTB/RIF result may be accepted as an alternative to a negative smear result. Respiratory specimen culture results may be positive or negative.
- No previous anti-tuberculosis treatment, or previous treatment resulting in successful cure, with treatment having been completed more than 2 years before enrollment.
Key exclusion criteria (9 listed)
- Positive AFB smear result from a respiratory specimen or gastric aspirate. A positive smear result from a lymph node specimen is permitted.
- Age younger than 3 months.
- One or more of the following forms of TB: miliary TB, tuberculous meningitis, osteoarticular TB, abdominal or gastrointestinal TB, genitourinary TB, or reproductive system TB.
- A non-tuberculosis condition that may affect treatment response or outcome assessment, including hepatic, renal, or cardiac disease; a corrected QT interval using Fridericia's formula (QTcF) greater than 450 ms in males or 470 ms in females; a condition requiring long-term immunosuppressive therapy; primary immunodeficiency; peripheral neuropathy; or cavitary disease.
- Contraindication to any anti-tuberculosis drug included in the assigned treatment regimen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-month FDC-based regimenAlso: 4FDC4-month fixed-dose combination (FDC) regimen | Drug | 4FDC |
| 3-month BDCZ regimenAlso: 3BDCZ3-month bedaquiline, delamanid, contezolid, and pyrazinamide (BDCZ) regimen | Drug | 3BDCZ |
| Standard 6-month treatment regimenAlso: 2HRZ(E)/4HRStandard 6-month treatment regimen, namely 2HRZ(E)/HR. | Drug | 2HRZ(E)/4HR |
Primary outcome
Tuberculosis-free survival at 12 months
Time frame: 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
Time frame: 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.
5 secondary outcomes
Tuberculosis recurrence at 12 months
Time frame: 12 months after treatment initiation
Treatment success and treatment failure at the end of treatment
Time frame: At the end of the assigned treatment regimen (3, 4, or 6 months)
Tuberculosis-free survival at 18 and 24 months
Time frame: 18 and 24 months after treatment initiation
Tuberculosis recurrence at 18 and 24 months
Time frame: 18 and 24 months after treatment initiation
Clinical outcomes at the end of follow-up
Time frame: 24 months after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4-month FDC-based regimen, 3-month BDCZ regimen and Standard 6-month treatment regimen in people with Tuberculosis, run by Huashan Hospital at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Li (13816829726, litaokc@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tuberculosis-free survival at 12 months (time frame: 12 months after treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.