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

Study acronym: INTENSE-TBM
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 24, 2026 (before its estimated September 23, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Sep 2025 to Sep 23, 2026
    • Study completion date: Apr 2026 to Sep 26, 2026
    • Publications: 1 to 2
    v7
  2. Primary completion date: Mar 2024 to Sep 2025
    • Study completion date: Dec 2024 to Apr 2026
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Primary completion date: Mar 30, 2023 to Mar 2024v4 Show 4 more changesShow less
    • Start date: Feb 9, 2020 to Feb 7, 2021
    • Study completion date: Dec 2023 to Dec 2024
    • Eligibility criteria revised
    • Study sites revised (13)
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jul 30, 2023 to Mar 30, 2023
    • Start date changed from estimate of Oct 1, 2020 to Feb 9, 2020
    • Site details revised at 13 of 13 sites
    v3
  6. Start date: Apr 1, 2020 to Oct 1, 2020v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04145258
Lead Sponsor ANRS, Emerging Infectious Diseases
Collaborators: European Union, European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions
(from sponsor)		 Tuberculous Meningitis
Related terms Tuberculosis, Meningeal
Enrollment 768 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov