Tuberculous meningitis in children
Conditions
Interventions
Experimental group:6-month treatment programme 6HRZLE
Control group:12-month treatment programme 2HRZE/10HR
Sponsors
Kunming Children's Hospital
Eligibility
Sex/Gender
All
Age
0.5 Years to 18 Years
Inclusion criteria
Inclusion criteria: (1) Age 6 months to 18 years. (2) Children diagnosed with first-treatment tuberculous meningitis. The definition of primary treatment needs to meet the criteria of Classification of Tuberculosis (WS196-2017). Diagnostic criteria need to meet the Expert Consensus on the Diagnosis of Tuberculous Meningitis in Children published by the Chinese Journal of Practical Pediatrics Clinics 2022. Diagnosis can be made if any of the criteria are met. ?Confirmation of diagnosis: Children with clinical manifestations of TBM who meet one of the following criteria: (1) Positive antacid staining of CSF smear; (2) CSF culture is positive for Mycobacterium avium subspecies, and the strain is identified as MTB complex group; (3) Positive MTB nucleic acid test of CSF; (4) Histopathological examination of the brain or spinal cord is consistent with pathological changes of tuberculosis, and the staining of antacid is positive or the molecular biology of the pathology is identified as MTB. ? Clinical diagnosis of cases after differential diagnosis to exclude other central nervous system diseases, CSF examination did not obtain a positive pathogenic result, and at the same time meet one of the following conditions: (1) The total score of the TBM diagnostic scoring system is =10 points (without cranial imaging results), and at least 2 points of the total score are from the CSF score; (2) A total TBM diagnostic scoring system score of =12 (with cranial imaging findings), with at least 2 of the total scores derived from CSF or cranial imaging scores. (3) Parents/legal guardians signed a written informed consent and were willing to be randomised to the treatment regimen of the trial and control groups according to the guidelines of the Ethics Committee.
Exclusion criteria
Exclusion criteria: (1) Comorbidities with other systemic diseases that may affect the assessment of treatment efficacy or serious life-threatening diseases. (2) Risk of drug resistance. (e.g., the patient is from an area with a high prevalence of drug-resistant TB. Close contacts are patients with drug-resistant tuberculosis), or at the time of enrolment, the child is known to have Mycobacterium tuberculosis isolates that are resistant to any one or more of the investigational drugs in this trial. (3) Known allergy to one or more of the study drugs or suffering from any known contraindication to taking the study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Clinical Symptom Indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| (2) Cerebrospinal fluid recovery;(3) Sequelae, complication occurrence;(4) Comprehensive quality of life assessment;(5)Growth, development and metabolic indicators;(6) Conversion of cerebrospinal fluid smears, cultures, and nucleic acid tests for Mycobacterium tuberculosis;(7) Imaging indicators;(8) Adverse drug reaction;(9) Relapse rate; | — |
Countries
China
Contacts
Public ContactLiu Xiaomei
Kunming Children's Hospital
Outcome results
None listed