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

Primary Purpose

Wound Infection

Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
E. coli Phages cocktail
Standard of care : Silver Sulfadiazine
P. Aeruginosa, Phages cocktail
Sponsored by
Pherecydes Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Infection focused on measuring Wound Infection in burned patient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Militaire Reine Astrid
  • CHU Sart-Tilman
  • Hôpital d'instruction des armées PercyRecruiting
  • Centre hospitalier ST Joseph et St Luc
  • Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

E. coli, Standard of care : Silver Sulfadiazine

E. coli, Phages cocktail

P. aeruginosa, Standard of care : Silver Sulfadiazine

P. aeruginosa, Phages cocktail

Arm Description

Burn wounds infected by E. coli treated with Standard of care : Silver Sulfadiazine

Burn wounds infected by E. coli treated with Pherecydes Pharma Phages cocktail

Burn wounds infected with P. aeruginosa treated with Standard of care : Silver Sulfadiazine

Burn wounds infected by P. aeruginosa treated treated with Pherecydes Pharma Phages cocktail

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 .
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.
number of sites cured
The number of infected burns or infected wounds getting a clinical improvement will be described and compared between treatment groups.

Full Information

First Posted
April 1, 2014
Last Updated
July 23, 2015
Sponsor
Pherecydes Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02116010
Brief Title
Evaluation of Phage Therapy for the Treatment of Escherichia Coli and Pseudomonas Aeruginosa Wound Infections in Burned Patients
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pherecydes Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
Keywords
Wound Infection in burned patient

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
E. coli, Standard of care : Silver Sulfadiazine
Arm Type
Active Comparator
Arm Description
Burn wounds infected by E. coli treated with Standard of care : Silver Sulfadiazine
Arm Title
E. coli, Phages cocktail
Arm Type
Experimental
Arm Description
Burn wounds infected by E. coli treated with Pherecydes Pharma Phages cocktail
Arm Title
P. aeruginosa, Standard of care : Silver Sulfadiazine
Arm Type
Active Comparator
Arm Description
Burn wounds infected with P. aeruginosa treated with Standard of care : Silver Sulfadiazine
Arm Title
P. aeruginosa, Phages cocktail
Arm Type
Experimental
Arm Description
Burn wounds infected by P. aeruginosa treated treated with Pherecydes Pharma Phages cocktail
Intervention Type
Drug
Intervention Name(s)
E. coli Phages cocktail
Intervention Description
Use of Pherecydes Pharma Phages cocktail to treat respectively E. coli burn wound infection
Intervention Type
Drug
Intervention Name(s)
Standard of care : Silver Sulfadiazine
Intervention Description
Use of Standard of care : Silver Sulfadiazine, to treat E. coli or P. aeruginosa infected burn wound
Intervention Type
Drug
Intervention Name(s)
P. Aeruginosa, Phages cocktail
Intervention Description
Use of Pherecydes Pharma Phages cocktail to treat P. aeruginosa burn wound infection
Primary Outcome Measure Information:
Title
Time for bacteria reduction adjusted on antibiotic treatment
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Assessment of tolerance of treatment
Description
Adverse events frequencies will be assessed in each treatment arms. Phages therapy safety profile will be compared to safety profile of standard of care .
Time Frame
21 days
Title
Incidence an delay of infection reduction with different bacterial species from the targets
Description
The criteria will be assessed according to wound clinical examination and bacteria count by the microbiologist.
Time Frame
7 days
Title
number of sites cured
Description
The number of infected burns or infected wounds getting a clinical improvement will be described and compared between treatment groups.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Jault, MD
Phone
+33 1 41 46 62 13
Email
patrick.jault@santarm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Cotton
Phone
+335 61 00 13 55
Email
christine.cotton@statitec.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Jault, MD
Organizational Affiliation
Service de Santé des Armées, Hopital Percy (Clamart, France)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Militaire Reine Astrid
City
Brussel
ZIP/Postal Code
B-1120
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Pirnay, PhD
Phone
+32 2 264 4844
Email
jean-paul.pirnay@mil.be
First Name & Middle Initial & Last Name & Degree
Serge Jennes, MD
Facility Name
CHU Sart-Tilman
City
Liege
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Françoise Rousseau, MD
Phone
+32 4 3667495
Email
afrousseau@chu.ulg.ac.be
First Name & Middle Initial & Last Name & Degree
Anne-Françoise Rousseau, MD
Facility Name
Hôpital d'instruction des armées Percy
City
Clamart
ZIP/Postal Code
92141
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Jault, MD
Phone
+33 (0)1 41 46 62 13
Email
patrick.jault@santarm.fr
First Name & Middle Initial & Last Name & Degree
Thomas Leclerc, MD
Phone
+33 (0)1 41 46 62 13
Email
thomas.leclerc@m4x.org
First Name & Middle Initial & Last Name & Degree
Patrick Jault, MD
First Name & Middle Initial & Last Name & Degree
Thomas Leclerc, MD
Facility Name
Centre hospitalier ST Joseph et St Luc
City
Lyon
ZIP/Postal Code
F-69365
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Ravat, MD
Phone
+33 (0) 478 618 925
Email
fravat@ch-stjoseph-stluc-lyon.fr
First Name & Middle Initial & Last Name & Degree
François Ravat, MD
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégory Resch, PhD
Phone
+41 21 692 56 23
Email
gregory.resch@unil.ch
First Name & Middle Initial & Last Name & Degree
Yok-Ai Que, Mer, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30292481
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.
Results Reference
derived

Learn more about this trial

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

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