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

Recruiting Phase 3 Interventional Study
Tuberculous Meningitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
15 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
768 (estimated)
Sponsor
ANRS, Emerging Infectious Diseases · Government
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About This Trial
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,…
Trial Locations
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Eligibility Criteria
Inclusion criteria: 1. Age ≥ 15 years 2. TBM defined as "definite", "probable" or "possible" 3. Signed Informed Consent * Definite TBM = at least one of the following criteria: acid-fast bacilli seen in CSF microscopy, positive CSF M. tuberculosis culture, or positive CSF M. tuberculosis commer…
Contacts

Fabrice Bonnet, M.D., Ph.D.

+33 (0)5 56 79 58 26

fabrice.bonnet@chu-bordeaux.fr

CONTACT

Xavier Anglaret, M.D., Ph.D.

+33 (0)5 57 57 12 58

xavier.anglaret@u-bordeaux.fr

CONTACT