Evaluation of Phage Therapy for the Treatment of Escherichia Coli and Pseudomonas Aeruginosa Wound Infections in Burned Patients

Phase 1

• Conditions: Wound Infection
• Interventions: Drug: E. coli Phages cocktail; Drug: P. Aeruginosa, Phages cocktail

• Registration Number: NCT02116010
• Lead Sponsor: Pherecydes Pharma

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-14
• Study First Posted: 2014-04-16
• Status Verified: 2015-07
• Study Start: 2015-07
• Last Update Submitted: 2015-07-23
• Last Update Posted: 2015-07-24
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E. coli, Phages cocktail	E. coli Phages cocktail	Burn wounds infected by E. coli treated with Pherecydes Pharma Phages cocktail
P. aeruginosa, Phages cocktail	P. Aeruginosa, Phages cocktail	Burn wounds infected by P. aeruginosa treated treated with Pherecydes Pharma Phages cocktail

Primary Outcome Measures

Name	Time	Method
Time for bacteria reduction adjusted on antibiotic treatment	7 days	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of tolerance of treatment	21 days	Adverse events frequencies will be assessed in each treatment arms. Phages therapy safety profile will be compared to safety profile of standard of care .
Incidence an delay of infection reduction with different bacterial species from the targets	7 days	The criteria will be assessed according to wound clinical examination and bacteria count by the microbiologist.
number of sites cured	7 days	The number of infected burns or infected wounds getting a clinical improvement will be described and compared between treatment groups.

Trial Locations

Locations (5)

Hopital Militaire Reine Astrid; 🇧🇪 Brussel, Belgium

CHU Sart-Tilman; 🇧🇪 Liege, Belgium

Centre hospitalier ST Joseph et St Luc; 🇫🇷 Lyon, France

Hôpital d'instruction des armées Percy; 🇫🇷 Clamart, France

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland