EFPIA - Kofinanzierung IMI-Clostridium Difficile Infections — COMBACTE-CDI

01.11.2017 bis 01.11.2020

Clostridium difficile infection (CDI) is one of the most prevalent healthcare associated infections,
affecting both hospitalized patients and individuals in the community.
Combating Bacterial Resistance in Europe-CDI (COMBACTE-CDI) 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 andtransmission 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 bacterial infections (including
those caused by antimicrobial-resistant bacteria), and a recently-started network that maps all
surveillance activities related to AMR in Europe (EPI-Net, also IMI-funded). COMBACTE-CDI,
therefore, maximizes the integration of previously initiated collaborations within Europe to develop
a detailed understanding of CDI burden, transmission, and control practices in Europe.
COMBACTE-CDI will have major impacts on European citizen health, significantly increase knowledge and expertise on CDI, providing a research platform to enable future clinical trials of novel CDI diagnostics, therapeutics and preventative options.