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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02116010
Other study ID # PHAGOBURN
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received April 1, 2014
Last updated July 23, 2015
Start date July 2015

Study information

Verified date July 2015
Source Pherecydes Pharma
Contact Patrick Jault, MD
Phone +33 1 41 46 62 13
Email patrick.jault@santarm.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santéBelgium : Agence Fédérale des Médicaments et des Produits de SantéSwitzeland : Suissmedic, Institut Suisse des produits thérapeutiques
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Belgium Hopital Militaire Reine Astrid Brussel
Belgium CHU Sart-Tilman Liege
France Hôpital d'instruction des armées Percy Clamart
France Centre hospitalier ST Joseph et St Luc Lyon
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne

Sponsors (1)

Lead Sponsor Collaborator
Pherecydes Pharma

Countries where clinical trial is conducted

Belgium,  France,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time for bacteria reduction adjusted on antibiotic treatment Time necessary for a persistent bacteria reduction of two modes or persistent bacteria eradication relative to D0 adjusted on antibiotic treatment (active on targeted strain) introduced between D1 to D7. Bacteria count performed on bacteria targeted by the phages cocktail collected from surface swab samples assessed by the microbiologist. 7 days No
Secondary Assessment of tolerance of treatment Adverse events frequencies will be assessed in each treatment arms. Phages therapy safety profile will be compared to safety profile of standard of care . 21 days Yes
Secondary Incidence an delay of infection reduction with different bacterial species from the targets The criteria will be assessed according to wound clinical examination and bacteria count by the microbiologist. 7 days No
Secondary number of sites cured The number of infected burns or infected wounds getting a clinical improvement will be described and compared between treatment groups. 7 days No
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