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Combatting Bacterial Resistance in Europe - Carbapenem Resistance

Objective

Multi-drug resistant Gram-negative bacteria (MDR-GNB): the ultimate challenge!
Antibiotic resistance is a global public health concern recently elevated to the top three threats identified by the WHO, and subject of numerous national and international government activities. Although focused strategies have beneficially influenced infection rates due to methicillin resistant Staphylococcus aureus (MRSA), infections due to MDR-GNB are rapidly increasing. In a very recent report the Centers for Disease Control and Prevention concluded that Carbapenem-Resistant Enterobacteriaceae (CRE) represent an immediate public health threat that requires urgent and aggressive action (CDC: Antibiotic Resistance Threats in the United States 2013).

The epidemiology of MDR-GNB, and especially of CRE, is characterized by large heterogeneity in genotypes (with >20 reported resistance genes, such as NDM, KPC, VIM, OXA-48) and even larger heterogeneity of phenotypes, seriously hampering rapid detection of resistant types when using routine susceptibility testing. Treatment of infections caused by CRE relies on combinations of “older” antibiotics, lacking a strong evidence base of effectiveness and safety. New treatments for these infections are, therefore, urgently needed.

The COMBACTE-CARE consortium is building on the recently funded Topic 1a/b/c consortium: COMBACTE, and contains three networks: CLIN-Net, LAB-Net and STAT-Net. To fulfil the specific objectives of Topic 5 the consortium has focussed on capacity building in clinical sites in some of the new member states in south-eastern Europe, where infection rates with MDR-GNB are expected to be high. Together with high-quality study sites in countries with endemic levels of MDR-GNB (such as Israel and Greece) CLIN-Net and LAB-Net will maximize capacity to provide a highly efficient resource for the conduct of the proposed studies on ATM-AVI. Furthermore, the consortium brings in four of the most prominent MDR-GNB diagnostic research groups in Europe, able to address the diagnostic challenges for the epidemiological and clinical studies, and a highly successful – and already operational – cohort for biomarker identification in critically ill patients. Furthermore, the participation of the PENTA network offers the unique opportunity to efficiently include neonates and children in the observational studies.

The COMBACTE-CARE consortium brings together 20 academic partners (10 also partner in COMBACTE) and two CROs that build upon prior EU Commission investments which present unique expertise and capabilities to the overall project partnership.

For all these reasons, APC2 (aligned with the COMBACTE infrastructure) will (1) increase the efficiency of antibiotic R&D through analysing observational clinical and microbiological data sets and making recommendations for the development of novel antibiotic agents for MDR GNB; will (2) provide new knowledge on the clinical management and outcomes of patients (neonates/children and adults) with serious hospitalised infections and will validate this knowledge for clinical outcomes for patients in areas of emerging and endemic antibiotic resistance; will (3) support the sustainability of ND4BB supported investigator and laboratory networks (COMBACTE); will (4) conduct prospective clinical trials with novel trial designs to deliver safety, pharmacology, and proof of efficacy data for novel agents directed towards treatment of infections due to MDR pathogens, prevention or sequelae of infections due to priority pathogens; will (5) validate novel bacterial identification and follow-up diagnostics or clinical endpoints with the aim of reducing the size and cost of clinical trials; and will (6) provide new knowledge on biomarkers predicting poor outcome in patients with serious healthcare-associated infections.

Call for proposal

IMI-JU-09-2013
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Coordinator

PFIZER LIMITED
Address
Ramsgate Road
CT13 9NJ Sandwich
United Kingdom

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Principal investigator
Rienk Pypstra (Dr)
Administrative Contact
Carla Cox (Mrs)

Participants (22)

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands
EU contribution
€ 9 521 813
Address
Heidelberglaan 100
3584 CX Utrecht

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Marco Perdon (Mr.)
UNIVERSITE DE GENEVE
Switzerland
EU contribution
€ 162 664
Address
Rue Du General Dufour 24
1211 Geneve

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Esther Bettiol (Dr)
Centre hospitalier universitaire de Limoges
France
EU contribution
€ 2 614 190
Address
Avenue Martin-luther-king 2
87000 Limoges

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Activity type
Research Organisations
Administrative Contact
Xavier Fretille (Financial Manager)
SERVICIO ANDALUZ DE SALUD
Spain
EU contribution
€ 4 104 556
Address
Avenida De La Constitucion 18
41071 Sevilla

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
SOPHIE MONTEAU (Ms)
KLINIKUM DER UNIVERSITAET ZU KOELN
Germany
EU contribution
€ 2 094 471
Address
Kerpener Strasse 62
50937 Koeln

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Jutta Landvogt (Mrs)
THE FOUNDATION FOR MEDICAL RESEARCH INFRASTRUCTURAL DEVELOPMENT AND HEALTH SERVICES NEXT TO THE MEDICAL CENTER TEL AVIV
Israel
EU contribution
€ 888 092
Address
Weizmann Street 6
64239 Tel Aviv

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Activity type
Research Organisations
Administrative Contact
Roll Michal (Dr.)
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
Greece
EU contribution
€ 698 000
Address
6 Christou Lada Str
10561 Athina

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Thomas Sfikopoulos (Professor)
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 532 800
Address
Rue De Tolbiac 101
75654 Paris

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Activity type
Research Organisations
Administrative Contact
Muriel BOUAS (Gestionnaire des ressources externes)
ST GEORGE'S HOSPITAL MEDICAL SCHOOL
United Kingdom
EU contribution
€ 247 500
Address
Cranmer Terrace
SW17 0RE London

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Steff Hazlehurst (Ms)
MINISTRIA E SHENDETESISE
Kosovo
EU contribution
€ 45 000
Address
Zagreb Street
10000 Pristina

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Naser Ramadani (PhD)
ACADEMISCH ZIEKENHUIS GRONINGEN

Participation ended

Netherlands
Address
Hanzeplein 1
9713 GZ Groningen

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Johan W. De Jong (Mr.)
THE HEALTH CORPORATION - RAMBAM
Israel
EU contribution
€ 522 200
Address
Haaliya 8
31096 Haifa

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Activity type
Research Organisations
Administrative Contact
Rivka Sevy (Ms.)
CARDIFF UNIVERSITY
United Kingdom
EU contribution
€ 211 039
Address
Newport Road 30 36
CF24 0DE Cardiff

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Keith Sexton (Dr)
SERVICIO MADRILENO DE SALUD
Spain
EU contribution
€ 176 900
Address
Plaza Carlos Trias Bertran 7
28020 Madrid

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
José Ignacio Flores Nicolás (Mr.)
FUNDACION PRIVADA INSTITUTO DE SALUD GLOBAL BARCELONA
Spain
EU contribution
€ 218 962
Address
C Rossello 132 Planta 05
08036 Barcelona

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Activity type
Research Organisations
Administrative Contact
Agnès MORAGUES (Ms)
ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM
Netherlands
EU contribution
€ 250 000
Address
Meibergdreef 15
1105AZ Amsterdam

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Gülseren Yalvac (-)
UNIVERSITEIT ANTWERPEN
Belgium
EU contribution
€ 1 209 313
Address
Prinsstraat 13
2000 Antwerpen

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Anne Adams (Mrs)
UNIVERSITAET ULM
Germany
EU contribution
€ 121 000
Address
Helmholtzstrasse 16
89081 Ulm

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Michaela Schuhmacher (Ms.)
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.
United Kingdom
Address
Great West Road 980
TW89GS Brentford

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Sally Miles (Mrs)
BASILEA PHARMACEUTICA INTERNATIONAL AG
Switzerland
Address
Grenzacherstrasse 487
4058 Basel

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Manfred Schulz (Dr)
ASTRAZENECA AB

Participation ended

Sweden
Address
Vastra Maelarhamnen
151 85 Sodertaelje

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Eva Lindgren (Senior Director)
UNIVERSITAETSKLINIKUM FREIBURG
Germany
EU contribution
€ 253 000
Address
Hugstetter Strasse 49
79106 Freiburg

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Jürgen Dreyer (Mr.)