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.

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.

While the project officially started on January 1st, 2019, the kick-off meeting brought together for the first time the international multidisciplinary consortium involved in INTENSE-TBM. The meeting of all key members of the project, from 7 countries marked the launch of a 5-year collaborative research period on tuberculosis meningitis.

As the first patient is expected to be included in 2020, the year 2019 is 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 sites set-up strategy in the 4 countries, the details of the doses and administration methods of some trial drugs, the trial monitoring plan, the content of the protocol, the pharmacokinetic and pharmacodynamic modelling, the TBM-HIV co-infection issues, the assessment of neurological impairment, or the dissemination to various audiences.