Adjunctive Linezolid for the Treatment of Tuberculous Meningitis
Status:
Recruiting
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
London School of Hygiene and Tropical Medicine MRC/UVRI and LSHTM Uganda Research Unit MRC/UVRI Uganda Research Unit on Aids