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Evaluation of phage therapy for the treatment of Escherichia coli and Pseudomonas aeruginosa burn wound infections (Phase I-II clinical trial)

Objective

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).

Field of science

  • /medical and health sciences/basic medicine/pathology
  • /natural sciences/biological sciences/microbiology/virology
  • /medical and health sciences/basic medicine/pharmacology and pharmacy/drug resistance/multidrug resistance

Call for proposal

FP7-HEALTH-2013-INNOVATION-2
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

MINISTERE DE LA DEFENSE
Address
Rue Saint Dominique, 14
75007 Paris
France
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
EU contribution
€ 210 236,48
Administrative Contact
Alexis Martin (Mr.)

Participants (4)

PHERECYDES PHARMA SA
France
EU contribution
€ 1 988 575,86
Address
Nantes Biotech 22 Boulevard Benoni Goullin
44200 Nantes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jérôme Gabard (Dr.)
CLEAN CELLS SAS
France
EU contribution
€ 1 259 087,97
Address
Rue Marie Curie - Parc Activites Vendee Sud Loire
85600 Boufféré
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Frederic Henry (Dr.)
ECOLE ROYALE MILITAIRE - KONINKLIJKE MILITAIRE SCHOOL
Belgium
EU contribution
€ 218 490,83
Address
Avenue De La Renaissance 30
1000 Bruxelles
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Nathalie Pattyn (Ms.)
CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS
Switzerland
EU contribution
€ 162 030,86
Address
Rue Du Bugnon 21
1011 Lausanne
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Linda Guihard (Ms.)