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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pherecydes Pharma
• Treatments: Silver Sulfadiazine; Sulfadiazine

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