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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

NCT05383742 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2025-12-02

No results posted yet for this study

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).

Conditions

  • Tuberculous Meningitis

Interventions

DRUG

Rifampicin (RIF)

Rifampicin 35 mg/kg

DRUG

Isoniazid (INH)

Isoniazid 10 or15 mg/kg

DRUG

Linezolid (LZD)

1200 mg

DRUG

Pyrazinamide (PZA)

25 mg/kg

DRUG

ethambutol (EMB)

20 mg/kg

DRUG

Rifampicin

10 mg/kg

DRUG

Isoniazid

5 mg/kg

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-07
Primary Completion
2028-04-30
Completion
2029-09-15
FDA Drug
Yes

Countries

  • Brazil
  • India
  • Kenya
  • Malawi
  • Mexico
  • Peru
  • Philippines
  • South Africa
  • Tanzania
  • Thailand
  • Vietnam
  • Zimbabwe

Study Locations

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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 NCT05383742 on ClinicalTrials.gov