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Clinical Trial Summary

This is a phase II randomized open-label trial of high versus standard dose rifampin (RIF) with or without linezolid (LZD) for the first 4 weeks of treatment for Tuberculosis Meningitis (TBM) at Masaka Regional Referral Hospital in Uganda. Initial randomization will be to high (35 mg/kg/day) versus standard (10 mg/kg/day) dose oral rifampin for the first 4 weeks of intensive therapy. Participants will then undergo a second randomization to linezolid 1200 mg daily versus no linezolid for the first 4 weeks of therapy. The primary aims are (1) to determine the cerebrospinal fluid and plasma pharmacokinetics of adjunctive LZD 1200 mg daily in TBM patients receiving high or standard dose RIF and (2) to evaluate the tolerability of a 4-week course of LZD in TBM patients.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04021121
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase Phase 2
Start date May 5, 2021
Completion date December 4, 2023

See also
  Status Clinical Trial Phase
Completed NCT03537495 - Pharmacokinetic Study of Linezolid for TB Meningitis Phase 2
Not yet recruiting NCT06446245 - Adjunctive Doxycycline for Central Nervous System Tuberculosis Phase 2
Completed NCT02958709 - Optimizing Treatment to Improve TBM Outcomes in Children Phase 1/Phase 2
Completed NCT02169882 - High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study Phase 2/Phase 3