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
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences health sciences public health epidemiology epidemics prevention
- medical and health sciences clinical medicine critical care medicine
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs antibiotics
- medical and health sciences basic medicine pharmacology and pharmacy drug resistance multidrug resistance
- medical and health sciences basic medicine pharmacology and pharmacy drug resistance antibiotic resistance
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
IMI-JU-11-2013
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Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)
Coordinator
151 85 Sodertaelje
Sweden
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Participants (39)
3584 CX Utrecht
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2000 Antwerpen
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1211 Geneve
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72074 Tuebingen
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6525 XZ Nijmegen
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41071 SEVILLA
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79106 Freiburg
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OX1 2JD Oxford
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89081 Ulm
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8006 Zurich
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75013 Paris
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08036 Barcelona
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1011 Lausanne
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28046 MADRID
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WC1E 6BT LONDON
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35127 Padova
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1050 Bruxelles / Brussel
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1105AZ Amsterdam
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07120 Palma
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87000 Limoges
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75654 PARIS
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42117 WUPPERTAL
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BS10 5NB Bristol
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3015 GD Rotterdam
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L69 7ZX LIVERPOOL
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RG6 1PT Reading
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Participation ended
BS8 1QU BRISTOL
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1180 Vienna
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08007 Barcelona
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1090 Wien
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WC1A 1DG LONDON
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4058 BASEL
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94250 Gentilly
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75012 Paris
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L7 8XP LIVERPOOL
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BS16 1QY BRISTOL
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1200 BRUXELLES
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69978 Tel Aviv
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37129 Verona
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