Wound InfectionPhase 1/2PHAGOBURNNCT02116010
Evaluation of Phage Therapy for the Treatment of Escherichia Coli and Pseudomonas Aeruginosa Wound Infections in Burned Patients
A Phase 1/2 study testing E. coli Phages cocktail and P. Aeruginosa, Phages cocktail in people with Wound Infection, run by Phagenix at 5 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection
- What is being tested?
- E. coli Phages cocktail and P. Aeruginosa, Phages cocktail
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 5 sitesin 3 countries
- Study dates
- Jul 2015to Jul 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Belgium2 sites, 2 recruiting
- Not yet recruiting
Hopital Militaire Reine Astrid
Brussels, B-1120
Jean-Paul Pirnay, PhD, +32 2 264 4844, jean-paul.pirnay@mil.be
Serge Jennes, MD
- Not yet recruiting
CHU Sart-Tilman
Liège
Anne-Françoise Rousseau, MD, +32 4 3667495, afrousseau@chu.ulg.ac.be
Anne-Françoise Rousseau, MD
France2 sites, 2 recruiting
- Recruiting
Hôpital d'instruction des armées Percy
Clamart, 92141
Patrick Jault, MD, +33 (0)1 41 46 62 13, patrick.jault@santarm.fr
Thomas Leclerc, MD, +33 (0)1 41 46 62 13, thomas.leclerc@m4x.org
- Not yet recruiting
Centre hospitalier ST Joseph et St Luc
Lyon, F-69365
François Ravat, MD, +33 (0) 478 618 925, fravat@ch-stjoseph-stluc-lyon.fr
François Ravat, MD
Switzerland1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
Grégory Resch, PhD, +41 21 692 56 23, gregory.resch@unil.ch
Yok-Ai Que, Mer, MD
About this study
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.
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.
Read the 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.
- Conditions
- Wound Infection
- Being tested
- E. coli Phages cocktail, Standard of care : Silver Sulfadiazine, P. Aeruginosa, Phages cocktail
- Keywords
- Wound Infection in burned patient
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E. coli Phages cocktailDrug
Use of Pherecydes Pharma Phages cocktail to treat respectively E. coli burn wound infection
Standard of care : Silver SulfadiazineDrug
Use of Standard of care : Silver Sulfadiazine, to treat E. coli or P. aeruginosa infected burn wound
P. Aeruginosa, Phages cocktailDrug
Use of Pherecydes Pharma Phages cocktail to treat P. aeruginosa burn wound infection
| Study group | Role | What they receive |
|---|---|---|
| E. coli, Standard of care : Silver Sulfadiazine | Active comparator | Burn wounds infected by E. coli treated with Standard of care : Silver Sulfadiazine Receives: Drug: Standard of care : Silver Sulfadiazine |
| E. coli, Phages cocktail | Experimental | Burn wounds infected by E. coli treated with Pherecydes Pharma Phages cocktail Receives: Drug: E. coli Phages cocktail |
| P. aeruginosa, Standard of care : Silver Sulfadiazine | Active comparator | Burn wounds infected with P. aeruginosa treated with Standard of care : Silver Sulfadiazine Receives: Drug: Standard of care : Silver Sulfadiazine |
| P. aeruginosa, Phages cocktail | Experimental | Burn wounds infected by P. aeruginosa treated treated with Pherecydes Pharma Phages cocktail Receives: Drug: P. Aeruginosa, Phages cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (3)
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 .
Measured: 21 days
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.
Measured: 7 days
number of sites cured
The number of infected burns or infected wounds getting a clinical improvement will be described and compared between treatment groups.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Phagenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Jault, MD, Principal investigator, Service de Santé des Armées, Hopital Percy (Clamart, France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116010
- Sponsor's protocol ID
- PHAGOBURN
- Acronym
- PHAGOBURN
- Status last verified
- Jul 2015
- First submitted
- 1 Apr 2014
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30292481
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02116010
- Acronym / sponsor ID
- PHAGOBURN / PHAGOBURN
- Conditions
- Wound Infection
- Keywords
- Wound Infection in burned patient
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- PhagenixIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| E. coli, Standard of care : Silver Sulfadiazine | Active comparator | Drug: Standard of care : Silver SulfadiazineBurn wounds infected by E. coli treated with Standard of care : Silver Sulfadiazine |
| E. coli, Phages cocktail | Experimental | Drug: E. coli Phages cocktailBurn wounds infected by E. coli treated with Pherecydes Pharma Phages cocktail |
| P. aeruginosa, Standard of care : Silver Sulfadiazine | Active comparator | Drug: Standard of care : Silver SulfadiazineBurn wounds infected with P. aeruginosa treated with Standard of care : Silver Sulfadiazine |
| P. aeruginosa, Phages cocktail | Experimental | Drug: P. Aeruginosa, Phages cocktailBurn wounds infected by P. aeruginosa treated treated with Pherecydes Pharma Phages cocktail |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Burn wounds with a microbiologically documented infection, as defined by positive surface swab, due to Escherichia coli or Pseudomonas aeruginosa whatever their resistance profile
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E. coli Phages cocktailUse of Pherecydes Pharma Phages cocktail to treat respectively E. coli burn wound infection | Drug | E. coli, Phages cocktail |
| Standard of care : Silver SulfadiazineUse of Standard of care : Silver Sulfadiazine, to treat E. coli or P. aeruginosa infected burn wound | Drug | E. coli, Standard of care : Silver Sulfadiazine, P. aeruginosa, Standard of care : Silver Sulfadiazine |
| P. Aeruginosa, Phages cocktailUse of Pherecydes Pharma Phages cocktail to treat P. aeruginosa burn wound infection | Drug | P. aeruginosa, Phages cocktail |
Primary outcome
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.
3 secondary outcomes
Assessment of tolerance of treatment
Time frame: 21 days
Incidence an delay of infection reduction with different bacterial species from the targets
Time frame: 7 days
number of sites cured
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
- Derived from this study: PubMed 30292481Jault 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Jault, MD principal investigator
Service de Santé des Armées, Hopital Percy (Clamart, France)
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing E. coli Phages cocktail and P. Aeruginosa, Phages cocktail in people with Wound Infection, run by Phagenix at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Jault, MD (+33 1 41 46 62 13, patrick.jault@santarm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for bacteria reduction adjusted on antibiotic treatment (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02116010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015.