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RecruitingPhase 3NCT04145258

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

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)

Sponsor

ANRS, Emerging Infectious Diseases

Enrollment

768 participants

Start Date

Feb 7, 2021

Study Type

INTERVENTIONAL

Conditions

Tuberculous Meningitis

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.

Eligibility

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a more intensive course of tuberculosis (TB) treatment can reduce deaths in patients who have TB in the brain — a severe condition called tuberculous meningitis. Standard TB treatment may not be strong enough to fight infection inside the brain, and this trial is exploring whether higher doses or different drug combinations improve survival. **You may be eligible if...** - You are 15 years or older - You have been diagnosed with definite, probable, or possible tuberculosis meningitis - You have signed (or a guardian has signed) an informed consent form **You may NOT be eligible if...** - You have already had more than 5 days of TB treatment - You have severe kidney problems (low eGFR) - You have a very low white blood cell count (neutrophils below 0.6) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAspirin

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

DRUGPlacebo 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)

DRUGWHO TBM treatment

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

DRUGIntensified 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

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