Short-Course TB Treatment for Children with Non-Severe Pulmonary TB

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase II, multicenter study, children aged 3 months to 18 years with non-severe, drug-susceptible pulmonary TB are randomized to three arms: a 3-month regimen with bedaquiline, delamanid, contezolid, and pyrazinamide; a 4-month fixed-dose combination regimen; or the standard 6-month regimen. The study compares tuberculosis-free survival at 12 months after starting treatment and tracks safety by grading adverse events. It aims to determine whether shortened regimens maintain efficacy while reducing treatment duration and improving adherence with child-friendly formulations. Open-label design means participants and researchers know the assigned regimen. Data will inform whether shorter courses can replace longer therapy in this population, particularly in China where implementation challenges exist.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.
* 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.

Where it's running

• Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province
  Fuzhou, Fujian, China Recruiting
• Guangzhou Chest Hospital
  Guangzhou, Guangdong, China Recruiting
• Guiyang Public Health Clinical Center
  Guiyang, Guizhou, China Recruiting
• Third People's Hospital of Liupanshui
  Liupanshui, Guizhou, China Recruiting
• Zunyi Infectious Diseases Hospital
  Zunyi, Guizhou, China Recruiting
• The Fifth People's Hospital of Suzhou
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Tao Li
• Email: litaokc@vip.163.com
• Phone: 13816829726

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.