Clinical trial NCT02116010: Evaluation of Phage Therapy for the Treatment of Escherichia Coli and Pseudomonas Aeruginosa Wound Infections in Burned Patients
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Wound Infection
Keywords: Wound Infection in burned patient
Lead sponsor: Phaxiam Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-04-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Time for bacteria reduction adjusted on antibiotic treatment
timeFrame: 7 days
Secondary outcomes:
measure: Assessment of tolerance of treatment
timeFrame: 21 days
measure: Incidence an delay of infection reduction with different bacterial species from the targets
timeFrame: 7 days
measure: number of sites cured
timeFrame: 7 days
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Hopital Militaire Reine Astrid
city: Liege
country: Belgium
facility: CHU Sart-Tilman
city: Clamart
country: France
facility: Hôpital d'instruction des armées Percy
city: Lyon
country: France
facility: Centre hospitalier ST Joseph et St Luc
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: Service de Santé des Armées, Hopital Percy (Clamart, France)
name: Patrick Jault, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jault P, Leclerc T, Jennes S, Pirnay JP, Que YA, Resch G, Rousseau AF, Ravat F, Carsin H, Le Floch R, Schaal JV, Soler C, Fevre C, Arnaud I, Bretaudeau L, Gabard J. Efficacy and tolerability of a cocktail of bacteriophages to treat burn wounds infected by Pseudomonas aeruginosa (PhagoBurn): a randomised, controlled, double-blind phase 1/2 trial. Lancet Infect Dis. 2019 Jan;19(1):35-45. doi: 10.1016/S1473-3099(18)30482-1. Epub 2018 Oct 3.