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Adjunctive Linezolid for the Treatment of Tuberculous Meningitis

NCT04021121 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-01

Study results available
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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

DRUG

LZD

LZD 1200 mg daily

DRUG

High dose RIF

RIF 35 mg/kg/day

DRUG

Standard dose RIF

RIF 10 mg/kg/day

Sponsors & Collaborators

  • MRC/UVRI and LSHTM Uganda Research Unit

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Felicia C Chow, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-05
Primary Completion
2023-07-05
Completion
2023-12-04

Countries

  • Uganda

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04021121 on ClinicalTrials.gov