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

Pherecydes Pharma

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Wound Infection

Treatments: Drug: E. coli Phages cocktail; Drug: P. Aeruginosa, Phages cocktail; Drug: Standard of care : Silver Sulfadiazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02116010

PHAGOBURN

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

E. coli, Standard of care : Silver Sulfadiazine

Active Comparator group

Description:

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

Treatment:

Drug: Standard of care : Silver Sulfadiazine

E. coli, Phages cocktail

Experimental group

Description:

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

Treatment:

Drug: E. coli Phages cocktail

P. aeruginosa, Standard of care : Silver Sulfadiazine

Active Comparator group

Description:

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

Treatment:

Drug: Standard of care : Silver Sulfadiazine

P. aeruginosa, Phages cocktail

Experimental group

Description:

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

Treatment:

Drug: P. Aeruginosa, Phages cocktail