A Phase 1/2 interventional study of E. coli Phages cocktail and Standard of care : Silver Sulfadiazine in Wound Infection, sponsored by Phaxiam Therapeutics. Status unknown at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-24.
Sponsored by Phaxiam Therapeutics · Phase 1/2, Interventional, and Treatment
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.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
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Burn wound (grafted or not) or graft harvesting area, presenting local signs of infection defined by SFETB criteria:
Exclusion Criteria:
Burn wounds infected by E. coli treated with Standard of care : Silver Sulfadiazine
Drug: Standard of care : Silver Sulfadiazine
Burn wounds infected by E. coli treated with Pherecydes Pharma Phages cocktail
Drug: E. coli Phages cocktail
Burn wounds infected with P. aeruginosa treated with Standard of care : Silver Sulfadiazine
Drug: Standard of care : Silver Sulfadiazine
Burn wounds infected by P. aeruginosa treated treated with Pherecydes Pharma Phages cocktail
Drug: P. Aeruginosa, Phages cocktail
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
Time 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
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Phaxiam Therapeutics