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Trial record 1 of 1 for:    phagoburn
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Evaluation of Phage Therapy for the Treatment of Escherichia Coli and Pseudomonas Aeruginosa Wound Infections in Burned Patients (PHAGOBURN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02116010
Recruitment Status : Unknown
Verified July 2015 by Pherecydes Pharma.
Recruitment status was:  Recruiting
First Posted : April 16, 2014
Last Update Posted : July 24, 2015
Sponsor:
Information provided by (Responsible Party):
Pherecydes Pharma

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.

Condition or disease Intervention/treatment Phase
Wound Infection Drug: E. coli Phages cocktail Drug: Standard of care : Silver Sulfadiazine Drug: P. Aeruginosa, Phages cocktail Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2015
Estimated Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: E. coli, Standard of care : Silver Sulfadiazine
Burn wounds infected by E. coli treated with Standard of care : Silver Sulfadiazine
Drug: Standard of care : Silver Sulfadiazine
Use of Standard of care : Silver Sulfadiazine, to treat E. coli or P. aeruginosa infected burn wound

Experimental: E. coli, Phages cocktail
Burn wounds infected by E. coli treated with Pherecydes Pharma Phages cocktail
Drug: E. coli Phages cocktail
Use of Pherecydes Pharma Phages cocktail to treat respectively E. coli burn wound infection

Active Comparator: P. aeruginosa, Standard of care : Silver Sulfadiazine
Burn wounds infected with P. aeruginosa treated with Standard of care : Silver Sulfadiazine
Drug: Standard of care : Silver Sulfadiazine
Use of Standard of care : Silver Sulfadiazine, to treat E. coli or P. aeruginosa infected burn wound

Experimental: P. aeruginosa, Phages cocktail
Burn wounds infected by P. aeruginosa treated treated with Pherecydes Pharma Phages cocktail
Drug: P. Aeruginosa, Phages cocktail
Use of Pherecydes Pharma Phages cocktail to treat P. aeruginosa burn wound infection




Primary Outcome Measures :
  1. Time for bacteria reduction adjusted on antibiotic treatment [ Time Frame: 7 days ]
    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 :
  1. Assessment of tolerance of treatment [ Time Frame: 21 days ]
    Adverse events frequencies will be assessed in each treatment arms. Phages therapy safety profile will be compared to safety profile of standard of care .

  2. Incidence an delay of infection reduction with different bacterial species from the targets [ Time Frame: 7 days ]
    The criteria will be assessed according to wound clinical examination and bacteria count by the microbiologist.

  3. number of sites cured [ Time Frame: 7 days ]
    The number of infected burns or infected wounds getting a clinical improvement will be described and compared between treatment groups.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116010


Contacts
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Contact: Patrick Jault, MD +33 1 41 46 62 13 patrick.jault@santarm.fr
Contact: Christine Cotton +335 61 00 13 55 christine.cotton@statitec.com

Locations
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Belgium
Hopital Militaire Reine Astrid Not yet recruiting
Brussel, Belgium, B-1120
Contact: Jean-Paul Pirnay, PhD    +32 2 264 4844    jean-paul.pirnay@mil.be   
Principal Investigator: Serge Jennes, MD         
CHU Sart-Tilman Not yet recruiting
Liege, Belgium
Contact: Anne-Françoise Rousseau, MD    +32 4 3667495    afrousseau@chu.ulg.ac.be   
Principal Investigator: Anne-Françoise Rousseau, MD         
France
Hôpital d'instruction des armées Percy Recruiting
Clamart, France, 92141
Contact: Patrick Jault, MD    +33 (0)1 41 46 62 13    patrick.jault@santarm.fr   
Contact: Thomas Leclerc, MD    +33 (0)1 41 46 62 13    thomas.leclerc@m4x.org   
Principal Investigator: Patrick Jault, MD         
Sub-Investigator: Thomas Leclerc, MD         
Centre hospitalier ST Joseph et St Luc Not yet recruiting
Lyon, France, F-69365
Contact: François Ravat, MD    +33 (0) 478 618 925    fravat@ch-stjoseph-stluc-lyon.fr   
Principal Investigator: François Ravat, MD         
Switzerland
Centre Hospitalier Universitaire Vaudois Not yet recruiting
Lausanne, Switzerland, CH-1011
Contact: Grégory Resch, PhD    +41 21 692 56 23    gregory.resch@unil.ch   
Principal Investigator: Yok-Ai Que, Mer, MD         
Sponsors and Collaborators
Pherecydes Pharma
Investigators
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Principal Investigator: Patrick Jault, MD Service de Santé des Armées, Hopital Percy (Clamart, France)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pherecydes Pharma
ClinicalTrials.gov Identifier: NCT02116010    
Other Study ID Numbers: PHAGOBURN
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015
Keywords provided by Pherecydes Pharma:
Wound Infection in burned patient
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Wound Infection
Wounds and Injuries
Sulfadiazine
Silver Sulfadiazine
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Anti-Infective Agents, Local