Severe drug-susceptible pulmonary tuberculosis in children
Conditions
Interventions
Group 1:"2HRZC/4HRC" short-course regimen
Group 2:"4BDCZ" Short-Course Regimen
Standard of Care:"2HRZE/7HR" Standard Regimen
Sponsors
West China Second University Hospital of Sichuan University (WCSUH- SCU)
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1.Age: >= 3 months and < 18 years old (18 years old excluded). 2.The diagnostic criteria shall comply with WS 288—2017, Health Industry Standard of the People's Republic of China,including: a. Confirmed cases; b. Clinically diagnosed cases. The subjects shall be children with newly treated pulmonary tuberculosis, and the definition of newly treated tuberculosis shall conform to the criteria specified in WS 196-2017, Classification of Tuberculosis. 3.Drug-susceptible pulmonary tuberculosis: a. Detection of Mycobacterium tuberculosis in respiratory specimens by Gene Xpert assay or pathogenic next-generation sequencing (NGS) assay, with negative results for all drug resistance genes of rifampicin (including isoniazid, pyrazinamide, ethambutol, and bedaquiline and delamanid which are used in the treatment regimen). b. No detection of the pathogen in respiratory specimens of the child by rapid molecular assay, and no definite risk factors for drug resistance. c. Respiratory specimens include: gastric juice, sputum, and bronchoalveolar lavage fluid (BAL; 4.Severe pulmonary tuberculosis is defined as meeting any of the following criteria: miliary pulmonary tuberculosis, tracheobronchial tuberculosis, pulmonary tuberculosis with cavities, etc.; in addition, it shall conform to the severe imaging criteria specified in Atlas of Chest Radiographs for the Diagnosis of Childhood Tuberculosis – Guidelines for the Interpretation of Chest X-rays, issued by the International Union Against Tuberculosis and Lung Disease (IUATLD) in 2022, including: tuberculous pleurisy complicated with massive pleural effusion or associated complications (such as lung consolidation, encapsulated pleural effusion, etc.); extensive lesion involvement: multi-lobar involvement; or involvement of a single lobe with the lesion range exceeding two-thirds of the lobe. 5.No prior anti-tuberculosis treatment has been received. 6.Willing to receive and complete the treatment course as well as the follow-up after drug withdrawal. 7.Written informed consent has been obtained from the parents or legal guardians.
Exclusion criteria
Exclusion criteria: 1.Extrapulmonary tuberculosis: defined as tuberculosis lesions occurring in organs and sites outside the lungs, such as lymph nodes (excluding intrathoracic lymph nodes), bones, joints, genitourinary system, digestive system, central nervous system, and other sites. 2.Complicated with other systemic diseases that may affect the evaluation of treatment efficacy or are life-threatening severe diseases. 3.Known hypersensitivity to one or more study drugs, or presence of any known contraindications to the administration of the study drugs. 4.Diagnosis of drug-resistant tuberculosis (DR-TB): a. Detection of drug resistance genes to rifampicin or any drug used in the treatment regimen by initial nucleic acid testing. b. Initial nucleic acid testing yields negative results, but respiratory specimen culture and drug susceptibility testing (DST) show resistance to any of rifampicin, isoniazid, pyrazinamide, or any drug included in the treatment regimen. (Subjects already enrolled in the study shall be withdrawn and treated according to the drug-resistant tuberculosis regimen. If subjects are screened into the BDCZ group, treatment may be continued or partial drugs may be adjusted with written permission from the parents, but they shall be excluded from the final intention-to-treat (ITT) analysis.) c. Initial nucleic acid testing, respiratory specimen culture, and drug susceptibility testing all yield negative results, but the subject has had close contact with an adult diagnosed with drug-resistant tuberculosis (including monoresistant tuberculosis) within 6 months prior to enrollment. 5.Poor compliance of the study participant as judged by the investigator, or other circumstances that the investigator deems inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tuberculosis Recurrence Rate;Severe adverse drug reactions;Favorable Outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cure Rate;Treatment Completion Rate;Treatment Success Rate; | — |
Countries
China
Contacts
Public ContactYu Zhu
West China Second University Hospital of Sichuan University (WCSUH- SCU)
Outcome results
None listed