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Combatting Bacterial Resistance in Europe - Clostridium Difficile Infections

Combatting Bacterial Resistance in Europe - Clostridium Difficile Infections

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 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
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Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT

Address

Heidelberglaan 100
3584 Cx Utrecht

Netherlands

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 429 653

Participants (13)

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UNIVERSITY OF LEEDS

United Kingdom

EU Contribution

€ 1 251 079

ACADEMISCH ZIEKENHUIS LEIDEN

Netherlands

EU Contribution

€ 137 676

NACIONALNI LABORATORIJ ZA ZDRAVJE, OKOLJE IN HRANO

Slovenia

EU Contribution

€ 90 557

KLINIKUM DER UNIVERSITAET ZU KOELN

Germany

EU Contribution

€ 151 848

UNIVERSITEIT ANTWERPEN

Belgium

EU Contribution

€ 58 556

ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI-ISTITUTO DI RICOVERO E CURA A CARATTERE SCIENTIFICO

Italy

EU Contribution

€ 150 260

EBERHARD KARLS UNIVERSITAET TUEBINGEN

Germany

EU Contribution

€ 42 676

PFIZER LIMITED

United Kingdom

GLAXOSMITHKLINE BIOLOGICALS SA

Belgium

BIOMERIEUX SA

France

ASTRAZENECA AB

Sweden

SANOFI PASTEUR SA

France

DA VOLTERRA SAS

France

Project information

Grant agreement ID: 777362

Status

Ongoing project

  • Start date

    1 November 2017

  • End date

    31 October 2020

Funded under:

H2020-EU.3.1.7.1.

  • Overall budget:

    € 4 582 218

  • EU contribution

    € 2 312 305

Coordinated by:

UNIVERSITAIR MEDISCH CENTRUM UTRECHT

Netherlands