Combatting Bacterial Resistance in Europe - Clostridium Difficile Infections (COMBACTE-CDI)

Framework: Horizon 2020 — Societal Challenges
Programme: Health, demographic change and wellbeing
Theme: Public-private partnerships
Destination: Innovative Medicines Initiative 2
Action type: Research and Innovation actions
Partnership: IMI2 (Art-187)
Countries involved: Germany,Germany,Italy,Belgium,Belgium,Sweden,Slovenia,France,France,Netherlands,Netherlands,United Kingdom,United Kingdom
Call: ADDRESSING THE CLINICAL BURDEN OF CLOSTRIDIUM DIFFICILE INFECTION (CDI): EVALUATION OF THE BURDEN, CURRENT PRACTICES AND SET-UP OF A EUROPEAN RESEARCH PLATFORM (PART OF THE IMI NEW DRUGS FOR BAD BUGS (ND4BB) PROGRAMME) (H2020-JTI-IMI2-2016-09-two-stage, 2016)
Start date: 2017-11-01
End date: 2021-04-30
Duration (months): 42.0
Total project cost (EUR): 4179307.0
EU funding (EUR): 2312305.0
Participants: 14
Project status: CLOSED

Clostridium difficile infection (CDI) is one of the most prevalent healthcare associated infections, affecting both hospitalized patients and individuals in the community; notably, there is an increasing realization that cases also occur in subjects not recently exposed to healthcare interventions, including antibiotics. CDI poses an extensive burden of morbidity, mortality and healthcare resource utilization, and so requires effective prevention and management strategies. Epidemiological data are, however, limited and studies typically have examined only part of a healthcare economy and usually have been focused on single countries/healthcare systems. Thus, there is a lack of robust, comprehensive data on the impact of CDI across countries in Europe. Furthermore, we know that large variations in the frequency of testing and the sensitivity of CDI diagnostics across European countries mean that the size of the problem is underestimated. Combating Bacterial Resistance in Europe-CDI (COMBACTE-CDI) therefore aims to develop a detailed understanding of the epidemiology and clinical impact of CDI across multiple European countries. Our project proposal provides a collaborative approach comprising three scientific work packages (WPs). A large epidemiology study will be undertaken across Europe in WP1 to quantify the burden of CDI (incidence, distribution, recurrence, morbidity, mortality, transmission) across the whole healthcare economy. This will be followed by a case/control study in WP2, which along with data collected in a questionnaire will enable the consortium to assess current practices in Europe (guidelines, testing, surveillance, treatment, cost) and their potential impacts. WP3 will create a rich, European, research platform that will provide support for future proof-of-concept and clinical studies of new prevention and treatment strategies for CDI. The three interrelated research WPs will be supported by a management work package (WP4). COMBACTE-CDI will harmonise with many of the IMI2 objectives; specifically, we aim to improve the health of European citizens by providing evidence of the true epidemiology and transmission of CDI. We will also develop ‘best-practice’ models for diagnosis, treatment and surveillance, which should reduce the incidence and impact of CDI (including mortality) across Europe, and will optimize patient management. Notably, in order to deliver these aims costeffectively and to test the resilience of our data, we will actively link and compare our data with other European projects that include CDI as a target condition. This synergistic approach will be all the more feasible as the participants in COMBACTE-CDI are playing key roles in multiple, relevant, parallel European CDI activities. Our ambitious proposal aims to go beyond the state of the art in 8 aspects: quantification of CDI in the whole healthcare economy; contemporaneous comparison with animal and food isolates with those within human health; identification of potential drivers of strain clustering, providing enhanced information to aid further trial/study design and conduct; use of a novel highly sensitive diagnostic assay for more accurate CDI case definition; provision of both cost-effectiveness and transmission models to enable further evaluation of interventions; and finally, by comparing overall costs in different European healthcare settings, we will, for the first time, allow simulation of the economic impact of novel CDI treatment options, even prior to market authorization. COMBACTE-CDI is the merger of excellent European expertise on the clinical, diagnostic, and therapeutic issues related to CDI and the expertise and input of 7 EFPIA partners. It brings together experts that partnered in CDI projects (EUCLID, ECDIS-NET), the largest existing (IMI-funded) clinical and laboratory network in Europe (CLIN-Net and LAB-Net) for successfully executing challenging epidemiological and interventional studies related to bacte

Keywords: clostridium difficile infection,research network,healthcare epidemiology,surveillance,prevention strategies,treatment strategies,combacte