Phagoburn clinical trial started in July 2015 (read the official press release).The finalised study synopsis is available online.
This randomised and monitored phase I/II single-blind trial is being conducted in 11 major burns units in France, Switzerland and Belgium (sponsor: Pherecydes):
- Percy Military Hospital (France) – project coordinator,
- Reine Astrid Hospital in Brussels (Belgium),
- Vaudois CHU (Switzerland),
- Sainte-Anne Military Hospital in Toulon (France),
- Liège teaching hospital (CHU) (Belgium),
- Grand-Hôpital of Charleroi-Loverval (Belgium),
- St. Joseph/St. Luc Hospital in Lyon (France),
- Nantes CHU (France),
- Bordeaux CHU (France),
- Metz-Thionville regional hospital (France),
- Marseille Conception hospital (France).
The study includes two arms of 110 patients each:
- One arm for burn wounds infected by Escherichia coli,
- The other arm for burn wounds infected by Pseudomonas aeruginosa.
The effect of the bacteriophages cocktails is compared to a reference antibiotic treatment (silver sulfadiazine).
The Primary Outcome Measure is the time for bacteria reduction adjusted on antibiotic treatment; the Secondary Outcome Measures are the assessment of treatment tolerance, the incidence on delay of infection reduction with different bacterial species from the targets, and the number of sites cured.