Shorter Treatment Regimens for Children With Non-Severe Lung Tuberculosis

Trial details

Who runs it

Huashan Hospital

Trial code

NCT07893444

Record updated

26 October 2026

Original description

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 full original descriptionShow less

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:

* 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.

Inclusion: 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; 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.

Exclusion: Close contact within 6 months before enrollment with an adult diagnosed with drug-resistant tuberculosis, including tuberculosis with resistance to a single drug; Diagnosis of drug-resistant TB before enrollment; Contraindication to any anti-tuberculosis drug included in the assigned treatment regimen; Critical illness; Any other condition that, in the investigator's judgment, makes the child unsuitable for participation in the study; 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; Age younger than 3 months; Positive AFB smear result from a respiratory specimen or gastric aspirate. A positive smear result from a lymph node specimen is permitted; 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.

ClinicalTrials.gov NCT07893444