Clinical study
PHAGOBURN
Evaluation of Phage Therapy for the Treatment of Escherichia Coli and Pseudomonas Aeruginosa Wound Infections in Burned Patients
| Status | Ended |
|---|---|
| Type | Trial |
| Countries | Belgium; Switzerland; France |
| Conditions studied | Wound Infection |
| Study years | 2015–2017 |
| Entry review | 2026-10-04 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
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 description
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.
Study registrations
| ClinicalTrials.gov | NCT02116010 |
|---|---|
| EUCTR | 2014-000714-65 |
Recorded study locations (5)
Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.
Hopital Militaire Reine Astrid
Brussels, Belgium
Recorded site status: Not yet recruiting. Study location source ↗
Hôpital d'instruction des armées Percy
Clamart, France
Recorded site status: Recruiting. Study location source ↗
Centre hospitalier ST Joseph et St Luc
Lyon, France
Recorded site status: Not yet recruiting. Study location source ↗
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Recorded site status: Not yet recruiting. Study location source ↗
Related programs(2)
PhagoBurn consortium
Historical/inactive
Recorded program–study link. Website
PHAXIAM Therapeutics / former Pherecydes pipeline
Historical/inactive
Recorded program–study link. Website
Related publications (1)
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
Study results — Relationship source
Notes from the source review
- Historical PhagoBurn: EUCTR2014-000714-65 results say global end2017-01-16. CTgov unknown is stale.
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
AI helped us research this directory. Details may be wrong or out of date. Confirm availability with the clinic or study team. Suggest a correction.
| Study ID | nct02116010 |
|---|