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Effectiveness and safety of shortened intensive treatment for children with tuberculous meningitis (SURE) a protocol for a phase 3 randomised controlled trial evaluating 6 months of antituberculosis therapy and 8 weeks of aspirin in Asian and African children with tuberculous meningitis

Effectiveness and safety of shortened intensive treatment for children with tuberculous meningitis (SURE) a protocol for a phase 3 randomised controlled trial evaluating 6 months of antituberculosis therapy and 8 weeks of aspirin in Asian and African children with tuberculous meningitis

 BMJ 2025
 Eng
Mô tả biểu ghi
ID:34053
NLM C22
Tác giả CN Phan Hữu Phúc
Nhan đề Effectiveness and safety of shortened intensive treatment for children with tuberculous meningitis (SURE): a protocol for a phase 3 randomised controlled trial evaluating 6 months of antituberculosis therapy and 8 weeks of aspirin in Asian and African children with tuberculous meningitis
Thông tin xuất bản 2025
Thông tin xuất bản BMJ
Tóm tắt 400 children (aged 29 days to <18 years) with clinically diagnosed TBM will be randomised, using a factorial design, to either a 24-week intensified regimen (isoniazid (20 mg/kg), rifampicin (30 mg/kg), pyrazinamide (40 mg/kg) and levofloxacin (20 mg/kg)) or the standard 48-week ATT regimen and 8 weeks of high-dose aspirin or placebo. The primary outcome for the first randomisation is all-cause mortality, and for the second randomisation is the paediatric modified Rankin Scale (mRS), both at 48 weeks. Nested substudies include pharmacokinetics, pharmacogenetics, pathophysiology, diagnostics and prognostic biomarkers, in-depth neurodevelopmental outcomes, MRI and health economics.
Thuật ngữ chủ đề Pediatric
Từ khóa tự do Clinical trials; Paediatric infectious disease
Địa chỉ 100Kho Bài báo quốc tế(1): BQT00123
Tệp tin điện tử https://pubmed.ncbi.nlm.nih.gov/40180374/
Tệp tin điện tử https://lib.hpmu.edu.vn/kiposdata2/tapchi2026/anhbiatc/biabbqt_thumbimage.jpg
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041[ ] |a Eng
084[ ] |a C22
100[ ] |a Phan Hữu Phúc
245[ ] |a Effectiveness and safety of shortened intensive treatment for children with tuberculous meningitis (SURE): a protocol for a phase 3 randomised controlled trial evaluating 6 months of antituberculosis therapy and 8 weeks of aspirin in Asian and African children with tuberculous meningitis
260[ ] |c 2025
260[ ] |b BMJ
520[ ] |a 400 children (aged 29 days to <18 years) with clinically diagnosed TBM will be randomised, using a factorial design, to either a 24-week intensified regimen (isoniazid (20 mg/kg), rifampicin (30 mg/kg), pyrazinamide (40 mg/kg) and levofloxacin (20 mg/kg)) or the standard 48-week ATT regimen and 8 weeks of high-dose aspirin or placebo. The primary outcome for the first randomisation is all-cause mortality, and for the second randomisation is the paediatric modified Rankin Scale (mRS), both at 48 weeks. Nested substudies include pharmacokinetics, pharmacogenetics, pathophysiology, diagnostics and prognostic biomarkers, in-depth neurodevelopmental outcomes, MRI and health economics.
650[ ] |a Pediatric
653[ ] |a Clinical trials
653[ ] |a Paediatric infectious disease
691[ ] |a CTĐT Tiến sĩ Nhi khoa
691[ ] |a CTĐT Bác sĩ nội trú Nhi khoa
773[ ] |t BMJ Open
852[ ] |a 100 |b Kho Bài báo quốc tế |j (1): BQT00123
856[ ] |u https://pubmed.ncbi.nlm.nih.gov/40180374/
856[1 ] |u https://lib.hpmu.edu.vn/kiposdata2/tapchi2026/anhbiatc/biabbqt_thumbimage.jpg
890[ ] |a 1 |b 0 |c 0 |d 0
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1 BQT00123 1 Kho Bài báo quốc tế
#1 BQT00123
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