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

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.