Evaluation of Phage Therapy for the Treatment of Escherichia Coli and Pseudomonas Aeruginosa Wound Infections in Burned Patients
NCT ID: NCT02116010
Last Updated: 2015-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
INTERVENTIONAL
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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E. coli, Standard of care : Silver Sulfadiazine
Burn wounds infected by E. coli treated with Standard of care : Silver Sulfadiazine
Standard of care : Silver Sulfadiazine
Use of Standard of care : Silver Sulfadiazine, to treat E. coli or P. aeruginosa infected burn wound
E. coli, Phages cocktail
Burn wounds infected by E. coli treated with Pherecydes Pharma Phages cocktail
E. coli Phages cocktail
Use of Pherecydes Pharma Phages cocktail to treat respectively E. coli burn wound infection
P. aeruginosa, Standard of care : Silver Sulfadiazine
Burn wounds infected with P. aeruginosa treated with Standard of care : Silver Sulfadiazine
Standard of care : Silver Sulfadiazine
Use of Standard of care : Silver Sulfadiazine, to treat E. coli or P. aeruginosa infected burn wound
P. aeruginosa, Phages cocktail
Burn wounds infected by P. aeruginosa treated treated with Pherecydes Pharma Phages cocktail
P. Aeruginosa, Phages cocktail
Use of Pherecydes Pharma Phages cocktail to treat P. aeruginosa burn wound infection
Interventions
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E. coli Phages cocktail
Use of Pherecydes Pharma Phages cocktail to treat respectively E. coli burn wound infection
Standard of care : Silver Sulfadiazine
Use of Standard of care : Silver Sulfadiazine, to treat E. coli or P. aeruginosa infected burn wound
P. Aeruginosa, Phages cocktail
Use of Pherecydes Pharma Phages cocktail to treat P. aeruginosa burn wound infection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Phaxiam Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick Jault, MD
Role: PRINCIPAL_INVESTIGATOR
Service de Santé des Armées, Hopital Percy (Clamart, France)
Locations
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Hopital Militaire Reine Astrid
Brussels, , Belgium
CHU Sart-Tilman
Liège, , Belgium
Hôpital d'instruction des armées Percy
Clamart, , France
Centre hospitalier ST Joseph et St Luc
Lyon, , France
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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PHAGOBURN
Identifier Type: -
Identifier Source: org_study_id
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