Clinical Trial

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

Recruiting Phase 2
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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).
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2022-05-16; most recent amendment 2026-06-01.
Status change: Suspended → Recruiting 2025-11-29
Status change: Recruiting → Suspended 2025-04-17
Status change: Not Yet Recruiting → Recruiting 2024-01-10
Trial Details
NCT Number NCT05383742
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Tuberculous Meningitis
Enrollment 330 participants
Start Date 2023-12-07
Primary Completion 2028-04-30 (estimated)
Study Completion 2029-09-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-02