Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
ANRS, Emerging Infectious Diseases French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP) European Union