Descrizione del progetto
Affrontare le malattie tropicali neglette tramite sperimentazioni cliniche adattative
Le malattie tropicali neglette sono un gruppo di infezioni parassitarie e batteriche che colpisce più di un milione di persone in tutto il mondo, per lo più nelle regioni a basso reddito. L’Africa sub-sahariana, con circa il 40 % dell’onere globale di malattie tropicali neglette, ne è interessata in misura sproporzionata. Il progetto eWHORM, finanziato dall’UE, si propone di migliorare le infrastrutture di ricerca clinica e istituire una piattaforma adattativa per la sperimentazione clinica. Nello specifico, svilupperà un farmaco che agisce in modo sicuro su molteplici specie di elminti. Valuterà l’efficacia del farmaco pan-nematodico oxfendazolo, economico e accessibile gratuitamente, in una sperimentazione clinica adattativa contro l’oncocercosi, la loiasi, la mansonellosi e la tricocefalosi. Il partenariato interdisciplinare tra otto paesi istituito dal progetto garantirà un rafforzamento delle capacità sostenibile all’interno dei paesi dell’Africa sub-sahariana e un approccio incentrato sul paziente alla mappatura di precisione per programmi di eliminazione.
Obiettivo
We will establish for the first time in NTDs an adaptive clinical trial platform and improve clinical research infrastructure in four SSA countries. A drug acting safely on multiple helminths species would be a major leap to tackle NTDs and enable the WHO RoadMap (eWHORM). The cheap and freely-accessible pan-nematode drug oxfendazole (OXF) has such potential. Given the limited portfolio of anthelmintic drug candidates, eWHORM will assess its efficacy in an adaptive clinical trial for simultaneous evaluation against onchocerciasis, loiasis, mansonellosis and trichuriasis. Thus not only the largest group of NTDs, but also diseases that are not (yet) listed will be adressed. This design significantly reduces patient numbers, development time-frames and enables treatment of co-infections. Combined with our highly sensitive molecular tests, we provide a patient-centric approach providing tools for targeted treatment (test and treat) and precision mapping for elimination programs. Strengthening of early career scientists in SSA in all aspects of clinical trial conduct and research including data management, simulation and statistical analysis, will be fostered by introducing a master and PhD program, a mentorship program as well as several webinars. An open-source virtual training and assessment tool for diagnosis of NTDs will complement the knowledge transfer to remote areas in SSA. The consortium encompasses an interdisciplinary partnership from eight different countries (Germany, the Netherlands, Austria, Switzerland, Cameroon, Gabon, Tanzania, and DRC). Each group brings unique knowhow and recognized complementary experience to the project to ensure sustainable capacity building within SSA countries. Through joint development of and training in modern, regulatory clinical trial conduct, adaptive clinical trial design and state-of-the-art diagnostics, we will strengthen SSA researchers and clinicians to respond to persisting and future health challenges.
Parole chiave
Programma(i)
- HORIZON.2.1 - Health Main Programme
Meccanismo di finanziamento
HORIZON-JU-RIA - HORIZON JU Research and Innovation ActionsCoordinatore
53127 Bonn
Germania