Tuberculosis in children
Conditions
Interventions
Experimental group:4-month treatment regimen [2HRZ(E)/2HR]
Control group:6-month treatment regimen [2HRZ (E)/4HR]
Sponsors
Kunming Children's Hospital
Eligibility
Sex/Gender
All
Age
12 Weeks to 18 Years
Inclusion criteria
Inclusion criteria: (1) Aged 3 months to 18 years. (2) Diagnosed as a child with primary tuberculosis. The definition of primary treatment should be in accordance with the criteria of the Classification of Tuberculosis (WS196-2017). Diagnostic criteria should be in accordance with the "Expert Consensus on the Diagnosis of Tuberculosis in Children, 2022 Edition" published by the Chinese Journal of Practical Pediatrics, 2022. Diagnosis can be made if any of the following criteria are met. ?Positive MTB culture of sputum, induced sputum, supporting alveolar lavage fluid, gastric fluid, feces, etc., or positive MTB nucleic acid in sub-groups for vitality testing, or positive pathology results. (Smear culture or GeneXpert) ?Clinically diagnosed cases should be considered to be clinically diagnosed if 3 of the following are present: 1) signs and symptoms of TB 2) imaging consistent with active TB lesions; and 3) positive TST and/or EC and/or IGRAs. (3) Non-serious TB in children: ?tuberculosis of intrathoracic lymph nodes without tract obstruction; ?simple tuberculous pleural effusion; ?non-cavitary disease confined to one lobe of the lungs with no granulomatous manifestations. (4) According to the guidance of the Ethics Committee, mother/legal guardian signed a written informed consent and was willing to be randomized to the treatment protocols of the experimental and control groups.
Exclusion criteria
Exclusion criteria: (1) Extra-pulmonary tuberculosis: Extra-pulmonary tuberculosis such as tuberculosis combined with tuberculous meningitis and tuberculosis of the joints. (2) Serious tuberculosis: refers to types of tuberculosis other than non-serious tuberculosis, such as disseminated tuberculosis, and tuberculosis with tubes supporting tubes. (3) Risk of drug resistance. (e.g. the patient is from a high incidence area of drug-resistant TB. close contacts are drug-resistant TB patients), or the Mycobacterium tuberculosis isolate is known to be resistant to any one or more of the investigational drugs in the trial at the time of entry into the cohort. (4) Comorbidities with other systemic diseases that may affect the assessment of the efficacy of treatment or serious life-threatening illness. (5) Known hypersensitivity to one or more of the investigational drugs or any known contraindication to the use of the investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Clinical symptom indicators;(3) Imaging indicators;(5) Etiology (including smear, culture, nucleic acid detection) turned negative;(7) Tuberculosis-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| (2)Growth and metabolic indicators;(4) Adverse drug reactions:;(6) Recurrence rate; | — |
Countries
China
Contacts
Public ContactLiuXiaomei
Kunming Children's Hospital
Outcome results
None listed