NCT04021121

Adjunctive Linezolid for the Treatment of Tuberculous Meningitis

Pharmacokinetics and Tolerability of Adjunctive Linezolid for the Treatment of Tuberculous Meningitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberculosis, Meningeal

Interventions

Type	Name	Description
DRUG	LZD	LZD 1200 mg daily
DRUG	High dose RIF	RIF 35 mg/kg/day
DRUG	Standard dose RIF	RIF 10 mg/kg/day

Timeline

• Start date: 2021-05-05
• Primary completion: 2023-07-05
• Completion: 2023-12-04
• First posted: 2019-07-16
• Last updated: 2024-10-01
• Results posted: 2024-10-01

Locations

1 site across 1 country: Uganda