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Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis
Sponsor: ANRS, Emerging Infectious Diseases
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.
Official title: Intensified Tuberculosis Treatment to Reduce the Mortality of HIV-infected and Uninfected Patients With Tuberculosis Meningitis: a Phase III Randomized Controlled Trial (Acronym: INTENSE-TBM)
Key Details
Gender
All
Age Range
15 Years - Any
Study Type
INTERVENTIONAL
Enrollment
768
Start Date
2021-02-07
Completion Date
2026-04
Last Updated
2024-01-22
Healthy Volunteers
No
Conditions
Interventions
Aspirin
Two tablets of aspirin 100 mg per day from inclusion (D-0) to end of Week-8 (W-8)
Placebo of aspirin
Two placebo tablets with the same appearance of aspirin 100 mg per day from inclusion (D-0) to end of Week-8 (W-8)
WHO TBM treatment
2 months of (R-H-Z-E) + 7 months of (R-H)
Intensified TBM treatment
2 months of (HDR-L-H-Z-E) + 7 months of (R-H), with HDR=high-dose rifampicin and L=linezolid
Locations (13)
Cocody University Hospital
Abidjan, Côte d’Ivoire
Treichville University Hospital
Abidjan, Côte d’Ivoire
Yopougon University Hospital
Abidjan, Côte d’Ivoire
University Hospital Joseph Raseta Befelatanana
Antananarivo, Madagascar
University Hospital Tambohobe
Fianarantsoa, Madagascar
Morafeno University Hospital
Toamasina, Madagascar
Kayelitsha District Hospital
Cape Town, South Africa
Mitchells Plain Hospital
Cape Town, South Africa
New Somerset Hospital
Cape Town, South Africa
Dora Nginza Hospital
Port Elizabeth, South Africa
Livingstone and PE Central Hospitals
Port Elizabeth, South Africa
Mbarara Regional Reference Hospital
Mbarara, Uganda
Regional Reference Hospital of Kabale
Mbarara, Uganda