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Combatting Bacterial Resistance in Europe - Molecules against Gram Negative Infections

Objective

Antimicrobial resistance (AMR) is a major global public health threat, and most troublesome is the rapid emergence and dissemination of multidrug resistant (MDR) Enterobacteriaceae, Acinetobacter species and Pseudomonas aeruginosa. There is an unmet medical need to prevent P. aeruginosa infection in critically ill patients and to develop new antibiotics for infections caused by Gram-negative bacteria (GNB). The Combatting Bacterial Resistance in Europe - Molecules against Gram Negative Infections (COMBACTE-MAGNET) consortium will provide groundbreaking multinational phase 2 and phase 3 studies in adult intensive care unit (ICU) patients and a phase 1 paediatric safety and PK study with the bispecific immunoglobulin (IgG)1 mAb (MEDI3902) targeting the pathogenic components PsI and PcrV as a new approach for preventing P. aeruginosa infections, especially pulmonary infections, in ICU patients. In addition, the consortium will perform phase 1 and phase 2 studies, including extensive pharmacokinetic/pharmacodynamic (PK/PD) studies, with a new beta‐lactam ‐ AIC499 ‐ with enhanced beta‐lactamase stability and in vitro/ in vivo activities against MDR-GNB, including P. aeruginosa and Acinetobacter spp. Alone, or in combination with a beta‐lactamase inhibitor (BLI), AIC499 is active against MDR isolates producing a wide range of beta‐lactamases, and therefore, offers the real prospect of a new treatment option for patients with life-threatening infections due to MDR GNBs. The COMBACTE-MAGNET consortium brings together 5 pharmaceutical industry partners and 36 academic partners, and is a true nexus of world class researchers from 10 European countries with expertise in (i) designing and executing observational and interventional studies related to antibiotic‐resistant bacteria; (ii) conducting high‐quality research in the epidemiology, prevention, and treatment of infections caused by MDR‐GNB, (iii) identifying novel biomarkers in critically ill patients; (iv) performing Phase I PK/PD studies; (v) performing Phase 2 studies enriched for PK/PD endpoints; and (vi) performance of large definitive Phase 3 randomized controlled trial (RCT) for regulatory purposes. The two European Federation of Pharmaceutical Industries and Associations (EFPIA) project sponsors, MedImmune and AiCuris, will provide all required study‐related expertise in clinical development of monoclonal antibodies and antibiotics with MEDI3902 and AIC499 plus BLI as Investigational Medicinal Products (IMPs), respectively. Key strengths of the COMBACTE-MAGNET consortium is its direct links to the ND4BB Topic 1 COMBACTE network (Clinical Trial Network [CLIN‐Net], Laboratory Trial and Research Network [LAB-Net], and Statistical Trial and Research Network [STAT‐net]), the ND4BB Topic 5 COMBACTE-CARE consortium, participation of the Paediatric European Network for the Treatment of AIDS and Infectious Diseases (PENTA-ID) network for pediatric infection studies, and the European Forum for Good Clinical Practice (EFGCP), a not‐for‐profit, Innovative Medicines Initiative (IMI)‐ and FP7‐funded, organization specialized in delivering tailor‐made, practice‐relevant Good Clinical Practice (GCP) training activities in European Union (EU) countries. The clinical studies related to MEDI3902 and of AIC499 will be supported by innovative epidemiological studies, including mathematical modeling of the consequences of P. aeruginosa infections. Furthermore, detailed biomarker studies will be performed to explore associations of host biomarkers (e.g. pre‐existing antibodies against P. aeruginosa virulence factors, protein biomarkers, and ribonucleic acid (RNA) molecules) and infections, disease severity and outcome, which will enhance the successful execution of clinical trials. Finally, COMBACTE-MAGNET will set up an unprecedented collaboration, called EPI-Net, to map and organize available surveillance systems in Europe in order to optimize surveillance o

Call for proposal

IMI-JU-11-2013
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Coordinator

ASTRAZENECA AB
Address
Vastra Maelarhamnen
151 85 Sodertaelje
Sweden

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Principal investigator
Hasan Jafri (MD)
Administrative Contact
Jörgen Jensen (Project Manager)

Participants (39)

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands
EU contribution
€ 5 439 736
Address
Heidelberglaan 100
3584 CX Utrecht

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Marco Perdon (-)
UNIVERSITEIT ANTWERPEN
Belgium
EU contribution
€ 3 827 750
Address
Prinsstraat 13
2000 Antwerpen

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Anne Adams (Mrs)
UNIVERSITE DE GENEVE
Switzerland
EU contribution
€ 735 943
Address
Rue Du General Dufour 24
1211 Geneve

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Esther Bettiol (Dr)
EBERHARD KARLS UNIVERSITAET TUEBINGEN
Germany
EU contribution
€ 1 160 700
Address
Geschwister-scholl-platz
72074 Tuebingen

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Clemens Lässing (Mr.)
STICHTING RADBOUD UNIVERSITEIT
Netherlands
EU contribution
€ 776 911
Address
Houtlaan 4
6525 XZ Nijmegen

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Michiel Gerlagh (Drs)
SERVICIO ANDALUZ DE SALUD
Spain
EU contribution
€ 1 021 770
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)
UNIVERSITAETSKLINIKUM FREIBURG
Germany
EU contribution
€ 471 150
Address
Hugstetter Strasse 49
79106 Freiburg

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Jürgen Dreyer (Mr.)
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
EU contribution
€ 180 000
Address
Wellington Square University Offices
OX1 2JD Oxford

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Gill Wells (Ms)
UNIVERSITAET ULM
Germany
EU contribution
€ 188 550
Address
Helmholtzstrasse 16
89081 Ulm

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Michaela Schuhmacher (Ms.)
UNIVERSITAT ZURICH
Switzerland
EU contribution
€ 148 050
Address
Ramistrasse 71
8006 Zurich

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Eveline Bielser (PhD)
INST CARDIOMETABOLISME NUTRITION ICAN
France
EU contribution
€ 301 900
Address
Boulevard De L'hopital 47-83
75013 Paris

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Activity type
Research Organisations
Administrative Contact
Noureddine FARAH (Mr)
CONSORCI INSTITUT D'INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER
Spain
EU contribution
€ 455 800
Address
Calle Rossello 149 Puerta Bjs
08036 Barcelona

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Activity type
Other
Administrative Contact
Pastora Martinez Samper (Dr)
CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS
Switzerland
EU contribution
€ 158 800
Address
Rue Du Bugnon 21
1011 Lausanne

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Thierry Borloz (Mr)
SERVICIO MADRILENO DE SALUD
Spain
EU contribution
€ 304 300
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
Jose Soto Bonel (Mr.)
UNIVERSITY COLLEGE LONDON
United Kingdom
EU contribution
€ 459 206
Address
Gower Street
WC1E 6BT London

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Malgorzata Kielbasa (Ms)
FONDAZIONE PENTA ONLUS
Italy
EU contribution
€ 1 924 200
Address
Corso Stati Uniti 4
35127 Padova

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Activity type
Research Organisations
Administrative Contact
Tommaso Rupolo (Mr.)
EUROPEAN FORUM FOR GOOD CLINICAL PRACTICE
Belgium
EU contribution
€ 120 000
Address
Rue De Washington 40
1050 Brussels

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Activity type
Other
Administrative Contact
Fanny SENEZ (-)
ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM
Netherlands
EU contribution
€ 562 500
Address
Meibergdreef 15
1105AZ Amsterdam

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Gülseren Yalvac (-)
Hospital Universitario Son Espases
Spain
EU contribution
€ 337 500
Address
Ctra. De Valldemossa
07120 Palma

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Elena Ferragut Roig (Law degree)
Centre hospitalier universitaire de Limoges
France
EU contribution
€ 33 878 494
Address
Avenue Martin-luther-king 2
87000 Limoges

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Activity type
Research Organisations
Administrative Contact
Xavier FRETILLE (Financial Manager)
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 210 450
Address
Rue De Tolbiac 101
75654 Paris

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Activity type
Research Organisations
Administrative Contact
Anthony LATTE (Mr)
AICURIS ANTI-INFECTIVE CURES AG
Germany
Address
Friedrich Ebert Strasse 475
42117 Wuppertal

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Holger Schmoll (-)
NORTH BRISTOL NATIONAL HEALTH SERVICE TRUST
United Kingdom
EU contribution
€ 14 260 731
Address
Southmead Hospital, Southmead Road, Westbury On Trym
BS10 5NB Bristol

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Activity type
Research Organisations
Administrative Contact
Rebecca Smith (Dr)
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
EU contribution
€ 262 185
Address
Dr Molewaterplein 40
3015 GD Rotterdam

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Wouter Roobol (Mr)
THE UNIVERSITY OF LIVERPOOL
United Kingdom
EU contribution
€ 372 031
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Jenny Lawson (Miss)
TranScrip Partners LLP
United Kingdom
EU contribution
€ 75 000
Address
Thames Valley Park Drive
RG6 1PT Reading

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Administrative Contact
Julia Lloyd-Parks (Senior Partner)
UNIVERSITY OF BRISTOL

Participation ended

United Kingdom
Address
Beacon House Queens Road
BS8 1QU Bristol
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Sarah Everett-Cox (Mrs)
Ursula Theuretzbacher
Austria
EU contribution
€ 205 000
Address
Eckpergasse
1180 Vienna

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ursula Theuretzbacher (Principal)
INSTITUT CATALA DE LA SALUT
Spain
EU contribution
€ 162 589
Address
Gran Via De Les Corts Catalanes 587
08007 Barcelona

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Lauren Fleming (Miss)
MEDIZINISCHE UNIVERSITAET WIEN
Austria
EU contribution
€ 1 974 430
Address
Spitalgasse 23
1090 Wien

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Markus Zeitlinger (MD)
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 (Ms)
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
Andreas Kümin (-)
SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT
France
Address
Pierre Brossolette 1
91380 Chilly Mazarin

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Olivier Brun (CHEF DE PROJETS)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 328 320
Address
3 Avenue Victoria
75000 Paris

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Activity type
Research Organisations
Administrative Contact
Patricia SCHOTT (Mrs)
ROYAL LIVERPOOL AND BROADGREEN UNIVERSITY HOSPITALS NHS TRUST
United Kingdom
EU contribution
€ 1 698 531
Address
Prescot Street
L7 8XP Liverpool

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Activity type
Research Organisations
Administrative Contact
Pam Neagle (EU Coordinator)
UNIVERSITY OF THE WEST OF ENGLAND, BRISTOL
United Kingdom
EU contribution
€ 272 539
Address
Frenchay Campus, Coldharbour Lane
BS16 1QY Bristol

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Brian Allen (Mr)
CLINIQUE UNIVERSITAIRE SAINT-LUC ASBL
Belgium
EU contribution
€ 663 000
Address
Avenue Hippocrate 10
1200 Bruxelles

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Activity type
Other
Administrative Contact
Renaud Mazy (Mr.)
TEL AVIV UNIVERSITY
Israel
EU contribution
€ 167 053
Address
Ramat Aviv
69978 Tel Aviv

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Lea Pais (Ms)
UNIVERSITA DEGLI STUDI DI VERONA
Italy
EU contribution
€ 2 234 881
Address
Via Dell Artigliere 8
37129 Verona

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Susanna Montalto (Dr)