Objectif Sepsis is the major problem of large burn patients and a predominant cause of death. The burn wound pathology, combined to a global intensive use of antibiotics (ATB), put patients at high risk of suffering from multidrug resistant (MDR) infections, notably carried out by the Gram-negative bacteria species: Pseudomonas aeruginosa or Escherichia coli. But the last Gram- ATB is more than 20 years old and impeded by spread out exponential resistance. New ATB with genuine mode of action to target current resistant types are out of scope. In this context, MDR Gram- infections are becoming orphan pathologies without treatment. Fighting MDR in burn trauma is becoming an urgent medical need through innovation.PHAGOBURN is focused on a highly promising alternative to ATB: phage therapy. Bacteriophages are viruses that specifically infect and kill bacteria during their replicative cycle. The main objective of the project is to assess the safety, effectiveness and pharmacodynamics of two therapeutic phage cocktails to treat either E. coli or P. aeruginosa burn wound infections. To reach that goal, a combined Phase I/II multicentric clinical trial will be carried out in 3 EU countries (France, Belgium, Switzerland), by different hospital burn units. Prior to that, a GMP bioproduction process will be implemented to produce both drug products according to current EMA standards. Meanwhile, the production process and the trial results will provide basis for an optimization of current regulatory guidelines.PHAGOBURN is coordinated by the French Ministry of Defence. The Consortium also includes the following partners: Pherecydes (French SME) and Clean Cells (French SME) for the GMP bioproduction of drug products, CHU Vaudois (CH) burn wards, as well as the Royal Military Academy of Belgium (Queen Astrid). Champ scientifique natural sciencesbiological sciencesmicrobiologybacteriologynatural sciencesbiological sciencesmicrobiologyvirologymedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsantibioticsmedical and health sciencesbasic medicinepathologymedical and health sciencesbasic medicinepharmacology and pharmacydrug resistancemultidrug resistance Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Thème(s) HEALTH.2013.2.3.1-1 - Drugs and vaccines for infections that have developed or are at the risk of developing significant anti-microbial resistance Appel à propositions FP7-HEALTH-2013-INNOVATION-2 Voir d’autres projets de cet appel Régime de financement CP-FP - Small or medium-scale focused research project Coordinateur MINISTERE DES ARMEES Contribution de l’UE € 210 236,48 Adresse RUE SAINT DOMINIQUE 14 75007 Paris France Voir sur la carte Région Ile-de-France Ile-de-France Paris Type d’activité Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Contact administratif Alexis Martin (Mr.) Liens Contacter l’organisation Opens in new window Coût total Aucune donnée Participants (4) Trier par ordre alphabétique Trier par contribution de l’UE Tout développer Tout réduire PHERECYDES PHARMA SA France Contribution de l’UE € 1 988 575,86 Adresse NANTES BIOTECH 22 BOULEVARD BENONI GOULLIN 44200 NANTES Voir sur la carte Région Pays de la Loire Pays de la Loire Loire-Atlantique Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Contact administratif Jérôme Gabard (Dr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée CLEAN CELLS SAS France Contribution de l’UE € 1 259 087,97 Adresse Rue Marie Curie - Parc Activites Vendee sud Loire 85600 Boufféré Voir sur la carte Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Contact administratif Frederic Henry (Dr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée ECOLE ROYALE MILITAIRE - KONINKLIJKE MILITAIRE SCHOOL Belgique Contribution de l’UE € 218 490,83 Adresse Avenue de la Renaissance 30 1000 Bruxelles / Brussel Voir sur la carte Région Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad Type d’activité Higher or Secondary Education Establishments Contact administratif Nathalie Pattyn (Ms.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS Suisse Contribution de l’UE € 162 030,86 Adresse RUE DU BUGNON 21 1011 Lausanne Voir sur la carte Région Schweiz/Suisse/Svizzera Région lémanique Vaud Type d’activité Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Contact administratif Linda Guihard (Ms.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée