Clinical Protocol

0

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.

LAISSER UN COMMENTAIRE

S'il vous plaît entrez votre commentaire!
S'il vous plaît entrez votre nom ici