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Intensified tuberculosis treatment to reduce the high mortality of tuberculous meningitis in HIV-infected and uninfected patients

Project description

Tuberculous meningitis treatment in Sub-Saharan Africa

Tuberculosis (TB) continues to pose a serious global health threat, with tuberculous meningitis (TBM) being the most severe form. Annually, an estimated 100 000 new cases arise, especially in sub-Saharan Africa, where TBM has a staggering mortality rate of 40 % among HIV-negative patients and up to 70 % for those co-infected with HIV. Traditional treatments, based on regimens for pulmonary TB, may not achieve optimal drug concentrations in the cerebrospinal fluid. In this context, the EU-funded INTENSE-TBM-2 project aims to reduce mortality and neurological complications associated with TBM. This extensive Phase III clinical trial will involve 768 patients across four sub-Saharan African countries, evaluating an intensified treatment regimen that includes high-dose rifampicin and linezolid.

Objective

Tuberculosis (TB) remains a global health problem. The most lethal and disabling form of TB is tuberculous meningitis (TBM), with an estimated 100,000 new cases occurring per year. In sub-Saharan Africa, TBM mortality reaches 40% in HIV negative patients and up to 70% in HIV co-infected patients. Since decades, TBM treatment is based on a regimen used against pulmonary TB, which probably results in suboptimal drug levels in the cerebrospinal fluid (CSF).

The main objective of INTENSE-TBM is to reduce the mortality and neurological complications of TBM in adults with or without HIV co-infection in sub-Saharan Africa (SSA). This is investigated via a multicentre randomised multicentre Phase III clinical trial involving 768 patients in four SSA countries to evaluate the efficacy of an intensified TB treatment regimen during the first two months of TB treatment, including high-dose rifampicin and linezolid (repurposed drug), with the addition of aspirin (not as yet authorized for TBM). This intensified TB treatment is expected to reduce mortality by at least 30% for each of the interventions and minimize neurological sequalae.


The INTENSE-TBM trial is the largest ongoing trial in the field of TBM worldwide. If superiority of this experimental arm is demonstrated in terms of reduced mortality, it will become the first Phase III study to demonstrate survival benefit from intensified TBM treatment.

As per the expected outcomes of this EDCTP-3 call, INTENSE-TBM-2, as the continuation of INTENSE-TBM, a clinical trial funded by EDCTP2 and whose activities were disrupted during the COVID-19 pandemic, aims at concluding the ongoing activities of the EDCTP-2 project. It also aims at complying with ethical issues, such as fully validating the willingness of trial participants to take part in the clinical investigations.

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Topic(s)

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Funding Scheme

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HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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Call for proposal

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(opens in new window) HORIZON-JU-GH-EDCTP3-2023-01

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Coordinator

UNIVERSITE DE BORDEAUX
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 136 562,50
Address
PLACE PEY BERLAND 35
33000 BORDEAUX
France

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Region
Nouvelle-Aquitaine Aquitaine Gironde
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 136 562,50

Participants (8)

Partners (1)

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