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

PHASE3RecruitingINTERVENTIONAL
Enrollment

768

Participants

Timeline

Start Date

February 7, 2021

Primary Completion Date

September 30, 2025

Study Completion Date

April 30, 2026

Conditions
Tuberculous Meningitis
Interventions
DRUG

Aspirin

Two tablets of aspirin 100 mg per day from inclusion (D-0) to end of Week-8 (W-8)

DRUG

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)

DRUG

WHO TBM treatment

2 months of (R-H-Z-E) + 7 months of (R-H)

DRUG

Intensified TBM treatment

2 months of (HDR-L-H-Z-E) + 7 months of (R-H), with HDR=high-dose rifampicin and L=linezolid

Trial Locations (13)

Unknown

NOT_YET_RECRUITING

Cocody University Hospital, Abidjan

RECRUITING

Treichville University Hospital, Abidjan

NOT_YET_RECRUITING

Yopougon University Hospital, Abidjan

RECRUITING

University Hospital Joseph Raseta Befelatanana, Antananarivo

RECRUITING

University Hospital Tambohobe, Fianarantsoa

NOT_YET_RECRUITING

Morafeno University Hospital, Toamasina

RECRUITING

Kayelitsha District Hospital, Cape Town

RECRUITING

Mitchells Plain Hospital, Cape Town

RECRUITING

New Somerset Hospital, Cape Town

RECRUITING

Dora Nginza Hospital, Port Elizabeth

RECRUITING

Livingstone and PE Central Hospitals, Port Elizabeth

RECRUITING

Mbarara Regional Reference Hospital, Mbarara

RECRUITING

Regional Reference Hospital of Kabale, Mbarara

All Listed Sponsors
collaborator

European Union

OTHER

collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

lead

ANRS, Emerging Infectious Diseases

OTHER_GOV