drugset / Trial / NCT05383742
Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare a 6-month regimen of high-dose rifampicin (RIF), high-dose isoniazid (INH), linezolid (LZD), and pyrazinamide (PZA) versus the World Health Organization (WHO) standard of care (SOC) treatment for tuberculosis meningitis (TBM).
Timeline
- Start
- 2023-12-07
- Primary completion
- 2028-04-30
- Completion
- 2029-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ethambutol | Small molecule | 20 mg/kg | — |
| Subject | Isoniazid | Small molecule | 5 mg/kg | — |
| Subject | Isoniazid | Small molecule | 10 mg/kg | — |
| Subject | Linezolid | Other / unclassified | 1200 mg | — |
| Subject | Pyrazinamide | Small molecule | 25 mg/kg | — |
| Subject | Rifampin | Small molecule | 10 mg/kg | Oral |
| Subject | Rifampin | Small molecule | 35 mg/kg | Oral |