Objetivo 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). Ámbito científico natural sciencesbiological sciencesmicrobiologybacteriologynatural sciencesbiological sciencesmicrobiologyvirologymedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsantibioticsmedical and health sciencesbasic medicinepathologymedical and health sciencesbasic medicinepharmacology and pharmacydrug resistancemultidrug resistance Programa(s) FP7-HEALTH - Specific Programme "Cooperation": Health Tema(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 Convocatoria de propuestas FP7-HEALTH-2013-INNOVATION-2 Consulte otros proyectos de esta convocatoria Régimen de financiación CP-FP - Small or medium-scale focused research project Coordinador MINISTERE DES ARMEES Aportación de la UE € 210 236,48 Dirección RUE SAINT DOMINIQUE 14 75007 Paris Francia Ver en el mapa Región Ile-de-France Ile-de-France Paris Tipo de actividad Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Contacto administrativo Alexis Martin (Mr.) Enlaces Contactar con la organización Opens in new window Coste total Sin datos Participantes (4) Ordenar alfabéticamente Ordenar por aportación de la UE Ampliar todo Contraer todo PHERECYDES PHARMA SA Francia Aportación de la UE € 1 988 575,86 Dirección NANTES BIOTECH 22 BOULEVARD BENONI GOULLIN 44200 NANTES Ver en el mapa Región Pays de la Loire Pays de la Loire Loire-Atlantique Tipo de actividad Private for-profit entities (excluding Higher or Secondary Education Establishments) Contacto administrativo Jérôme Gabard (Dr.) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos CLEAN CELLS SAS Francia Aportación de la UE € 1 259 087,97 Dirección Rue Marie Curie - Parc Activites Vendee sud Loire 85600 Boufféré Ver en el mapa Tipo de actividad Private for-profit entities (excluding Higher or Secondary Education Establishments) Contacto administrativo Frederic Henry (Dr.) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos ECOLE ROYALE MILITAIRE - KONINKLIJKE MILITAIRE SCHOOL Bélgica Aportación de la UE € 218 490,83 Dirección Avenue de la Renaissance 30 1000 Bruxelles / Brussel Ver en el mapa Región Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad Tipo de actividad Higher or Secondary Education Establishments Contacto administrativo Nathalie Pattyn (Ms.) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS Suiza Aportación de la UE € 162 030,86 Dirección RUE DU BUGNON 21 1011 Lausanne Ver en el mapa Región Schweiz/Suisse/Svizzera Région lémanique Vaud Tipo de actividad Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Contacto administrativo Linda Guihard (Ms.) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos