BRIGHT-Child TB: Short-Course Treatment for Non-Severe Pulmonary Tuberculosis in Children

Prior treatment

• 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.

Other illness

• 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.

Lab values

• 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

• Age younger than 3 months.

Other

• 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.

• 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.