COMBACTE-CDI · Combatting Bacterial Resistance in Europe - Clostridium Difficile Infections

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 anincreasing realization that cases also occur in subjects not recently exposed to healthcareinterventions, including antibiotics. CDI poses an extensive burden of morbidity, mortality andhealthcare resource utilization, and so requires effective prevention and management strategies.Epidemiological data are, however, limited and studies typically have examined only part of ahealthcare 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 CDIdiagnostics across European countries mean that the size of the problem is underestimated.Combating Bacterial Resistance in Europe-CDI (COMBACTE-CDI) therefore aims todevelop a detailed understanding of the epidemiology and clinical impact of CDI across multipleEuropean countries. Our project proposal provides a collaborative approach comprising threescientific work packages (WPs). A large epidemiology study will be undertaken across Europe inWP1 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 inWP2, which along with data collected in a questionnaire will enable the consortium to assesscurrent practices in Europe (guidelines, testing, surveillance, treatment, cost) and their potentialimpacts. WP3 will create a rich, European, research platform that will provide support for futureproof-of-concept and clinical studies of new prevention and treatment strategies for CDI. The threeinterrelated research WPs will be supported by a management work package (WP4).COMBACTE-CDI will harmonise with many of the IMI2 objectives; specifically, we aim toimprove the health of European citizens by providing evidence of the true epidemiology andtransmission of CDI. We will also develop ‘best-practice’ models for diagnosis, treatment andsurveillance, which should reduce the incidence and impact of CDI (including mortality) acrossEurope, and will optimize patient management. Notably, in order to deliver these aims costeffectivelyand to test the resilience of our data, we will actively link and compare our data withother European projects that include CDI as a target condition. This synergistic approach will be allthe 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 ofCDI in the whole healthcare economy; contemporaneous comparison with animal and food isolateswith those within human health; identification of potential drivers of strain clustering, providingenhanced information to aid further trial/study design and conduct; use of a novel highly sensitivediagnostic assay for more accurate CDI case definition; provision of both cost-effectiveness andtransmission models to enable further evaluation of interventions; and finally, by comparing overallcosts in different European healthcare settings, we will, for the first time, allow simulation of theeconomic 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 togetherexperts 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 executingchallenging epidemiological and interventional studies related to bacte