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RECRUITING
NCT04145258
PHASE3

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

Sponsor: ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

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

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

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