The objective of PHAGOBURN is to assess tolerance and efficacy of local bacteriophage treatment of E. coli or P. aeruginosa wound infections in burned patients.
PHAGOBURN is a Phase I/II clinical trial randomized, multicentric, open label, standard of care (Silver Sulfadiazine) controlled aiming at assessing tolerance and efficacy of local bacteriophage treatment of wound infections due to E. coli or P. aeruginosa in burned patients using Pherecydes Pharma anti-Escherichia coli and anti-Pseudomonas aeruginosa bacteriophage cocktails GMP produced. This project is a European Research \& Development (R\&D) project funded by the European Commission under the 7th Framework Programme for Research and Development. This project is involving 7 clinical sites in EU.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Use of Pherecydes Pharma Phages cocktail to treat respectively E. coli burn wound infection
Use of Standard of care : Silver Sulfadiazine, to treat E. coli or P. aeruginosa infected burn wound
Use of Pherecydes Pharma Phages cocktail to treat P. aeruginosa burn wound infection
Hopital Militaire Reine Astrid
Brussels, Belgium
NOT_YET_RECRUITINGCHU Sart-Tilman
Liège, Belgium
NOT_YET_RECRUITINGHôpital d'instruction des armées Percy
Clamart, France
RECRUITINGTime for bacteria reduction adjusted on antibiotic treatment
Time necessary for a persistent bacteria reduction of two modes or persistent bacteria eradication relative to D0 adjusted on antibiotic treatment (active on targeted strain) introduced between D1 to D7. Bacteria count performed on bacteria targeted by the phages cocktail collected from surface swab samples assessed by the microbiologist.
Time frame: 7 days
Assessment of tolerance of treatment
Adverse events frequencies will be assessed in each treatment arms. Phages therapy safety profile will be compared to safety profile of standard of care .
Time frame: 21 days
Incidence an delay of infection reduction with different bacterial species from the targets
The criteria will be assessed according to wound clinical examination and bacteria count by the microbiologist.
Time frame: 7 days
number of sites cured
The number of infected burns or infected wounds getting a clinical improvement will be described and compared between treatment groups.
Time frame: 7 days
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Centre hospitalier ST Joseph et St Luc
Lyon, France
NOT_YET_RECRUITINGCentre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
NOT_YET_RECRUITING