INTENSE-TBM project launch
The launch meeting for the INTENSE-TBM project, coordinated by the University of Bordeaux, was held in March in Abidjan (Ivory Coast). The aim of this project is to improve, on a global level, the care of those affected by tuberculosis meningitis.
The meeting marked the launch of the INTENSE-TBM 5-year international project, funded by the European & Developing Countries Clinical Trials Partnership (EDCTP2), sponsored by Inserm-ANRS, and coordinated by the University of Bordeaux.
Aims of the INTENSE-TBM project
The aim of the INTENSE-TBM is to bring about global improvement in the care of those affected by tuberculosis meningitis. It includes a randomized clinical trial with factorial design in 4 African countries (South Africa, Ivory Coast, Madagascar and Uganda). The aim of this trial is to assess, firstly, the efficiency of intensified antituberculosis therapy for TBM, combining a high dose of rifampicin, an antibiotic routinely used for tuberculosis, and a second antibiotic - linezolid not previously used in this context - for the first two months of treatment in addition to conventional tuberculosis therapy; and secondly, the addition or not of aspirin to inhibit platelet aggregation. This intensified therapy is expected to reduce mortality rates by 30% and minimize the neurological after-effects induced by TBM.
Tuberculous meningitis or tuberculosis meningitis (TBM)
Tuberculosis is an infectious disease caused by Koch's bacillus (Mycobacterium tuberculosis), which is an airborne pathogen. In 2017, the World Health Organization (WHO) estimated that tuberculosis caused 1.3 million deaths. The disease generally affects the lungs, but may also migrate to other organs, such as the brain. This is known as tuberculosis meningitis (TBM), the most severe form of tuberculosis, most frequently affecting children, young adults, and HIV infection/AIDS carriers. Around 40% of those suffering from TBM die in the weeks following meningeal infection, and half of the survivors have potentially severe neurological after-effects.
Launch meeting in Abidjan
While the project officially commenced on January 1st, 2019, this launch meeting made it possible to bring the international multidisciplinary consortium involved in INTENSE-TBM together for the first time. The key members of the project, from 7 countries, thus marked the commencement of 5 years of collaborative research on tuberculosis meningitis.
As the first patient is expected to be included in January 2020, the year 2019 represents the trial preparation phase. In this context, this first meeting offered the partners the opportunity to reach a consensus on a number of topics that still needed to be discussed: the trial site set-up strategy in the 4 countries, details of the doses and administration methods of certain trial drugs, the trial monitoring plan, details of the protocol, pharmacokinetic and pharmacodynamic modelling, TBM-HIV co-infection, assessment of neurological after-effects, or broadcasting to various audiences, etc.
Inserm, University of Bordeaux, IDIBAPS (Institut d'investigacions Biomèdiques August Pi i Sunyer), University of Cape Town, the French National Research Institute for Development, the PAC-CI program , Epicentre, the Charles Merieux Center for Infectious Disease, University of Geneva, Institut Pasteur de Madagascar
The INTENSE-TBM project is part of the EDCTP2 Programme supported by the European Union (grant RIA2017T-2019) and is sponsored by Inserm‐ANRS (ANRS 12398 INTENSE‐TBM).