Objectif
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
Champ scientifique
- medical and health scienceshealth sciencespublic healthepidemiologyepidemics prevention
- medical and health sciencesclinical medicinecritical care medicine
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsantibiotics
- medical and health sciencesbasic medicinepharmacology and pharmacydrug resistancemultidrug resistance
- medical and health sciencesbasic medicinepharmacology and pharmacydrug resistanceantibiotic resistance
Appel à propositions
IMI-JU-11-2013
Voir d’autres projets de cet appel
Régime de financement
JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)Coordinateur
151 85 Sodertaelje
Suède
Voir sur la carte
Participants (39)
3584 CX Utrecht
Voir sur la carte
2000 Antwerpen
Voir sur la carte
1211 Geneve
Voir sur la carte
72074 Tuebingen
Voir sur la carte
6525 XZ Nijmegen
Voir sur la carte
41071 Sevilla
Voir sur la carte
79106 Freiburg
Voir sur la carte
OX1 2JD Oxford
Voir sur la carte
89081 Ulm
Voir sur la carte
8006 Zurich
Voir sur la carte
75013 Paris
Voir sur la carte
08036 Barcelona
Voir sur la carte
1011 Lausanne
Voir sur la carte
28046 MADRID
Voir sur la carte
WC1E 6BT London
Voir sur la carte
35127 Padova
Voir sur la carte
1050 Bruxelles / Brussel
Voir sur la carte
1105AZ Amsterdam
Voir sur la carte
07120 Palma
Voir sur la carte
87000 Limoges
Voir sur la carte
75654 Paris
Voir sur la carte
42117 Wuppertal
Voir sur la carte
BS10 5NB Bristol
Voir sur la carte
3015 GD Rotterdam
Voir sur la carte
L69 7ZX Liverpool
Voir sur la carte
RG6 1PT Reading
Voir sur la carte
Participation terminée
BS8 1QU Bristol
Voir sur la carte
1180 Vienna
Voir sur la carte
08007 Barcelona
Voir sur la carte
1090 Wien
Voir sur la carte
TW89GS Brentford
Voir sur la carte
4058 BASEL
Voir sur la carte
94250 GENTILLY
Voir sur la carte
75012 Paris
Voir sur la carte
L7 8XP LIVERPOOL
Voir sur la carte
BS16 1QY Bristol
Voir sur la carte
1200 Bruxelles / Brussel
Voir sur la carte
69978 Tel Aviv
Voir sur la carte
37129 Verona
Voir sur la carte