Project description DEENESFRITPL United Europe against Clostridium difficile infections Clostridium difficile is a bacterium that can cause infections in the colon and lead to a range of symptoms, from mild diarrhoea to severe inflammation. Despite its prevalence, associated morbidity and healthcare costs, comprehensive data on the impact of Clostridium difficile infection (CDI) across Europe is lacking. The EU-funded COMBACTE-CDI project aims to better understand the epidemiology and clinical impact of CDI. The consortium will collect information on current practices and their effectiveness and establish a platform for future research studies. The project is expected to address various aspects of CDI by combining scientific and clinical expertise, as well as leveraging the contributions of industry partners. Show the project objective Hide the project objective Objective 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 Fields of science social sciencessociologydemographymortalitynatural sciencesbiological sciencesmicrobiologybacteriologymedical and health scienceshealth sciencespublic healthepidemiologymedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsantibiotics Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.7. - Innovative Medicines Initiative 2 (IMI2) Topic(s) IMI2-2016-09-01 - 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) Call for proposal H2020-JTI-IMI2-2016-09-two-stage See other projects for this call Funding Scheme IMI2-RIA - Research and Innovation action Coordinator UNIVERSITAIR MEDISCH CENTRUM UTRECHT Net EU contribution € 350 255,46 Address HEIDELBERGLAAN 100 3584 CX Utrecht Netherlands See on map Region West-Nederland Utrecht Utrecht Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 441 140,00 Participants (13) Sort alphabetically Sort by Net EU contribution Expand all Collapse all UNIVERSITY OF LEEDS United Kingdom Net EU contribution € 1 330 476,54 Address WOODHOUSE LANE LS2 9JT Leeds See on map Region Yorkshire and the Humber West Yorkshire Leeds Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 1 675 710,00 ACADEMISCH ZIEKENHUIS LEIDEN Netherlands Net EU contribution € 137 676,00 Address ALBINUSDREEF 2 2333 ZA Leiden See on map Region West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 173 400,00 NACIONALNI LABORATORIJ ZA ZDRAVJE, OKOLJE IN HRANO Slovenia Net EU contribution € 90 557,00 Address PRVOMAJSKA ULICA 1 2000 Maribor See on map Region Slovenija Vzhodna Slovenija Podravska Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 114 055,00 KLINIKUM DER UNIVERSITAET ZU KOELN Germany Net EU contribution € 151 848,00 Address Kerpener Strasse 62 50937 Koeln See on map Region Nordrhein-Westfalen Köln Köln, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 191 250,00 UNIVERSITEIT ANTWERPEN Belgium Net EU contribution € 58 556,00 Address PRINSSTRAAT 13 2000 Antwerpen See on map Region Vlaams Gewest Prov. Antwerpen Arr. Antwerpen Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 73 750,00 ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI-ISTITUTO DI RICOVERO E CURA A CARATTERE SCIENTIFICO Italy Net EU contribution € 150 260,00 Address Via Portuense, 292 00149 Roma See on map Region Centro (IT) Lazio Roma Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 189 250,00 EBERHARD KARLS UNIVERSITAET TUEBINGEN Germany Net EU contribution € 42 676,00 Address GESCHWISTER-SCHOLL-PLATZ 72074 Tuebingen See on map Region Baden-Württemberg Tübingen Tübingen, Landkreis Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 53 750,00 PFIZER LIMITED United Kingdom Net EU contribution € 0,00 Address RAMSGATE ROAD CT13 9NJ Sandwich See on map Region South East (England) Kent East Kent Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 271 200,00 GLAXOSMITHKLINE BIOLOGICALS SA Belgium Net EU contribution € 0,00 Address RUE DE L INSTITUT 89 1330 Rixensart See on map Region Région wallonne Prov. Brabant Wallon Arr. Nivelles Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 150 000,00 BIOMERIEUX SA France Net EU contribution € 0,00 Address Chemin de l'Orme 69280 Marcy l'Etoile See on map Region Auvergne-Rhône-Alpes Rhône-Alpes Rhône Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 521 000,00 ASTRAZENECA AB Participation ended Sweden Net EU contribution € 0,00 Address Vastra Maelarhamnen 151 85 Sodertaelje See on map Region Östra Sverige Stockholm Stockholms län Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 43 089,00 SANOFI PASTEUR SA France Net EU contribution € 0,00 Address 14 ESPACE HENRY VALLEE 69007 Lyon See on map Region Auvergne-Rhône-Alpes Rhône-Alpes Rhône Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 60 913,00 DA VOLTERRA SAS France Net EU contribution € 0,00 Address RUE DE CHARONNE 172 LE DORIAN BATIMENT B 75011 PARIS See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Ile-de-France Ile-de-France Paris Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 220 800,00