PhagoBurn: the world first multicenter clinical study of phage therapy in serious burn victims
Launched in June 2013, the European collaborative project PhagoBurn (www.phagoburn.eu) assesses the tolerance and efficacy of bacteriophages to fight against skin infections in burn wounds due to sensitive and resistant-to-antibiotics bacteria. In burn patients, infections are indeed the first cause of mortality, especially as bacterial strains increasingly acquire high levels of resistance to antibiotics, often leading to death because of therapeutic dead-end.
The study final results are expected for late March or early April 2017.
The PhagoBurn trial started in July 2015 in 11 burn unit centers in France, Belgium and Switzerland. In this phase I/II, randomized, controlled, single-blind clinical study, two cocktails of bacteriophages were respectively tested against two bacterial strains associated with burns infections: Pseudomonas aeruginosa and Escherichia coli. However, the low number of patients infected by E. coli that could enter the clinical trial led the partners to focus only on the anti-Pseudomonas aeruginosa phage treatment, in June 2016. Originally sized with a hundred patients per phage product evaluation, the somehow low level of patient inclusion transformed also the study in a proof of concept.
PhagoBurn is the first clinical study on phage therapy that meets international standards of clinical assessment. Coordinated by the French Defense Health Service (Ministry of Defense) through the Percy Armed Forces Teaching Hospital, the trial received all necessary clinical authorizations by regulatory agencies and ethical committees in all three involved countries before being launched. In addition to Percy Hospital, the PhagoBurn study involves two other military hospitals (Queen Astrid, Brussels and Sainte-Anne Armed Forces Teaching Hospital, Toulon) as well as eight civilian ones: CHU Liège and Charleroi-Loverval Grand Hospital (Belgium), CHU Vaudois (Switzerland), Lyon Saint Joseph Saint Luc Hospital, CHU Nantes, CHU Bordeaux, CHR Metz-Thionville and Marseille Hospital of the Conception (France).
Apart from Pherecydes Pharma, the PhagoBurn project includes another SME, Clean Cells (France), which produced the bacteriophages cocktails according to current pharmaceutical requirements.
PhagoBurn is funded under the 7th European Framework Programme for research and development (FP7).