Trial | NCT02116010  Report issue

Title

Evaluation of Phage Therapy for the Treatment of Escherichia Coli and Pseudomonas Aeruginosa Wound Infections in Burned Patients
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 Bacteriophages GMP Produced Cocktails . This Project is a European Research & Development (R&D) Project Funded by the European Commission Under the 7th Framework Programme for Research and Development Involving 7 Clinical Sites in EU.

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    None
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 Started
Jul 31
2015
Primary Completion
Jul 31
2016
Anticipated
Last Update
Jul 24
2015
Estimate

Drug E. coli Phages cocktail

Use of Pherecydes Pharma Phages cocktail to treat respectively E. coli burn wound infection

Drug Standard of care : Silver Sulfadiazine

Use of Standard of care : Silver Sulfadiazine, to treat E. coli or P. aeruginosa infected burn wound

Drug P. Aeruginosa, Phages cocktail

Use of Pherecydes Pharma Phages cocktail to treat P. aeruginosa burn wound infection

E. coli, Standard of care : Silver Sulfadiazine Active Comparator

Burn wounds infected by E. coli treated with Standard of care : Silver Sulfadiazine

E. coli, Phages cocktail Experimental

Burn wounds infected by E. coli treated with Pherecydes Pharma Phages cocktail

P. aeruginosa, Standard of care : Silver Sulfadiazine Active Comparator

Burn wounds infected with P. aeruginosa treated with Standard of care : Silver Sulfadiazine

P. aeruginosa, Phages cocktail Experimental

Burn wounds infected by P. aeruginosa treated treated with Pherecydes Pharma Phages cocktail

Criteria 

Inclusion Criteria:

Man or woman
Adult Informed consent obtained from patient or next of kin
In-hospital patient treated for burn wounds in a burn unit

Burn wound (grafted or not) or graft harvesting area, presenting local signs of infection defined by SFETB criteria:

A local or loco-regional inflammatory reaction;
And/or an adverse and unexpected local evolution;
And/or regarding burn wounds: presence of pus, fast spontaneous debridement and separation, occurrence of blackish spots (necrosis or haemorrhage), unexplained conversion from a superficial lesion to a deep one (> 48th hour);
And/or regarding graft donor sites: presence of pus, unexplained delay in epidermisation, bedsore;
And/or regarding graft recipient sites: presence of pus, lysis of grafts, necrosis of fat located under the graft.
Burn wounds with a microbiologically documented infection, as defined by positive surface swab, due to Escherichia coli or Pseudomonas aeruginosa whatever their resistance profile
Treated by povidone-iodine

Exclusion Criteria:

Pregnant or breastfeeding woman
Intercurrent condition requiring a treatment which may interfere with analysis results: such as high dose of chronic corticotherapy, immunosuppressive medication, oncologic chemotherapy
Patient included in an interventional research protocol with therapeutic intervention still ongoing upon inclusion time or having participated into anti-infective drug trials during the previous month.
Patient considered as part of a vulnerable population
Patient for whom treatment limitation or withdrawal during study period is considered
Allergy to Silver Sulfadiazine
No Results Posted