The kick-off meeting of the INTENSE-TBM project was held in Abidjan, Côte d’Ivoire, on March 21 and 22, 2019 in the premises of the PAC-CI program, one of the project partners. It marked the beginning of this five-year international project, funded by EDCTP2 (The European & Developing Countries Clinical Trials Partnership), sponsored by Inserm-ANRS and coordinated by the University of Bordeaux.
Tuberculosis meningitis (TBM)
Tuberculosis is an infectious disease caused by the Koch bacillus (Mycobacterium tuberculosis) that is transmitted by air. The World Health Organization (WHO) estimated that tuberculosis was responsible for 1.6 million deaths in 2016. The disease typically affects the lungs, but can also migrate to all organs, such as the meninges. Tuberculous meningitis (TBM) is the most serious form of tuberculosis and most commonly affects children, young adults and people with HIV / AIDS. About 40% of people with TBM die in the weeks following the meningeal attack and half of the survivors have neurological sequelae that may be serious.
The objective of the INTENSE-TBM project is to improve overall management of people with TBM. It includes a randomized clinical trial with factorial design in 4 African countries (South Africa, Ivory Coast, Madagascar and Uganda) with adult patients. One the one hand, it aims at evaluating the effectiveness of an intensified tuberculosis treatment of tuberculosis, associating a high dose of an antibiotic usually used in tuberculosis – the rifampicine – and a second antibiotic – the linezolid hitherto not used in this context – during the first two months of treatment, in addition to the conventional treatment of tuberculosis. On the other hand, it will assess the addition or not of aspirin for anti-platelet aggregation. This intensified treatment is expected to reduce the mortality rate by 30% and minimize neurological sequelae.
Abidjan kick-off meeting
While the project officially started on January 1, 2019, this kick-off meeting brought together for the first time the international and multidisciplinary INTENSE-TBM consortium. Within this consortium, some of the participants have had working relationships for many years and others met for the first time in Abidjan. All the key members of the project, coming from 7 countries, made this trip for this important stage of the life of the project, marking the beginning of 5 years of collaborative work around TBM.
The inclusion of the first patient being expected in January 2020, the year 2019 constitutes the preparation phase of the trial. In this context, this first meeting gave the partners the opportunity to reach consensus on several subjects that still needed to be discussed: the strategy for setting up the trial sites in the four countries, the precision of the doses and administration modes of drugs in the trial, the monitoring plan of the trial, the details of the protocol, the pharmacokinetic and pharmacodynamic modeling, the TBM-HIV co-infection, the evaluation of neurological sequelae, the dissemination to different audiences …