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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

Call for proposal

H2020-JTI-IMI2-2016-09-two-stage
See other projects for this call

Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Address
Heidelberglaan 100
3584 CX Utrecht
Netherlands
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 350 255,46

Participants (13)

UNIVERSITY OF LEEDS
United Kingdom
EU contribution
€ 1 330 476,54
Address
Woodhouse Lane
LS2 9JT Leeds
Activity type
Higher or Secondary Education Establishments
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
EU contribution
€ 137 676
Address
Albinusdreef 2
2333 ZA Leiden
Activity type
Higher or Secondary Education Establishments
NACIONALNI LABORATORIJ ZA ZDRAVJE, OKOLJE IN HRANO
Slovenia
EU contribution
€ 90 557
Address
Prvomajska Ulica 1
2000 Maribor
Activity type
Research Organisations
KLINIKUM DER UNIVERSITAET ZU KOELN
Germany
EU contribution
€ 151 848
Address
Kerpener Strasse 62
50937 Koeln
Activity type
Higher or Secondary Education Establishments
UNIVERSITEIT ANTWERPEN
Belgium
EU contribution
€ 58 556
Address
Prinsstraat 13
2000 Antwerpen
Activity type
Higher or Secondary Education Establishments
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI-ISTITUTO DI RICOVERO E CURA A CARATTERE SCIENTIFICO
Italy
EU contribution
€ 150 260
Address
Via Portuense, 292
00149 Roma
Activity type
Research Organisations
EBERHARD KARLS UNIVERSITAET TUEBINGEN
Germany
EU contribution
€ 42 676
Address
Geschwister-scholl-platz
72074 Tuebingen
Activity type
Higher or Secondary Education Establishments
PFIZER LIMITED
United Kingdom
EU contribution
€ 0
Address
Ramsgate Road
CT13 9NJ Sandwich
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
GLAXOSMITHKLINE BIOLOGICALS SA
Belgium
EU contribution
€ 0
Address
Rue De L Institut 89
1330 Rixensart
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BIOMERIEUX SA
France
EU contribution
€ 0
Address
Chemin De L'orme
69280 Marcy L'etoile
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ASTRAZENECA AB

Participation ended

Sweden
EU contribution
€ 0
Address
Vastra Maelarhamnen
151 85 Sodertaelje
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SANOFI PASTEUR SA
France
EU contribution
€ 0
Address
14 Espace Henry Vallee
69007 Lyon
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
DA VOLTERRA SAS
France
EU contribution
€ 0
Address
Rue De Charonne 172 Le Dorian Batiment B
75011 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)