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

Wound Infection Clinical Trial

— PHAGOBURN  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02116010
• Other study ID #: PHAGOBURN
• 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. 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

• Communicable Diseases
• Infection
• Wound Infection

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