Clinical Trial

Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis

Study acronym: INTENSE-TBM
Recruiting Phase 3
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Summary
INTENSE-TBM is randomized controlled, phase III, multicenter, 2 x 2 factorial plan superiority trial assessing the efficacity of two interventions to reduce mortality from tuberculous meningitis (TBM) in adolescents and adults with or without HIV-infection in sub-Saharan Africa: * Intensified TBM treatment with high-dose rifampicin and linezolid, compared to WHO standard TBM treatment. * Aspirin, compared to not receiving aspirin. The trial will be open-label for anti-TB treatment and placebo-controlled for aspirin treatment.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2019-10-28; most recent amendment 2026-06-21.
Status change: Not Yet Recruiting → Recruiting 2021-02-11
Trial Details
NCT Number NCT04145258
Lead Sponsor ANRS, Emerging Infectious Diseases
Collaborators: European Union, European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions Tuberculous Meningitis
Enrollment 768 participants
Start Date 2021-02-07
Primary Completion 2026-09-23 (estimated)
Study Completion 2026-09-26 (estimated)
Updated on ClinicalTrials.gov 2026-06-24