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    Summary
    EudraCT Number:2014-000714-65
    Sponsor's Protocol Code Number:PHAGOBURN
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-21
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-000714-65
    A.3Full title of the trial
    Evaluation of phage therapy for the treatment of Pseudomonas aeruginosa wound infections in burned patients (Phase I-II clinical trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of phage therapy for the treatment of Pseudomonas aeruginosa wound infections in burned patients (Phase I-II clinical trial)
    Infection bactérienne chez les brûlés
    A.3.2Name or abbreviated title of the trial where available
    PHAGOBURN
    A.4.1Sponsor's protocol code numberPHAGOBURN
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02116010
    A.5.4Other Identifiers
    Name:Pherecydes PharmaNumber:PP
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPherecydes Pharma SA
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPherecydes Pharma
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportService de Santé des Armées
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportQueen Astrid Hospital
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportUniversity Hospital Lausanne
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportFP7 project number 601857
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStatitec
    B.5.2Functional name of contact pointGoulven Theze
    B.5.3 Address:
    B.5.3.1Street Address80 rue Pierre et Marie Curie
    B.5.3.2Town/ cityLabege Innopole
    B.5.3.3Post code31670
    B.5.3.4CountryFrance
    B.5.4Telephone number33612546299
    B.5.5Fax number335 61 00 98 30
    B.5.6E-mailgoulven.theze@statitec.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNone
    D.3.2Product code PP1131
    D.3.4Pharmaceutical form Concentrate and solvent for cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Cutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSULFADIAZINE
    D.3.9.1CAS number 68-35-9
    D.3.9.4EV Substance CodeSUB10695MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeBacteriophages cocktails obtained through bacterial production
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    P. aeruginosa infected wound in burned patients.
    Third degree wound burn infected by Pseudomonas aeruginosa. Hospîtalized patients in ICU's.
    E.1.1.1Medical condition in easily understood language
    Bacterial infected wound in burned patients
    Infections bactériennes ches les grands brûlés
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of PHAGOBURN study is to assess the efficacy and safety of topical applications of PP1131 bacteriophage cocktail, targeting P. aeruginosa infected third degree wounds in hospitalized patients, in comparison to silver sulfadiazine treatment.
    E.2.2Secondary objectives of the trial
    • Assessment of tolerance of treatment
    • Incidence and delay of infection with different bacterial species from the targets
    • Incidence and timing of severe sepsis or septic shock attributable to E coli or P aeruginosa
    • Reasons for patient’s withdrawal from study (tolerance, graft …)
    • Number of sites cured
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Man or woman 18 years old or more
    Informed consent obtained from patient or next of kin
    In-hospital patient treated for burn wounds in a burn unit
    Burn wounds with a microbiologically documented infection defined by positive surface swab, due to P. aeruginosa whatever their resistance profile.
    As poly-microbial infections are usual in burn wounds infection, when one another bacterial specie is also present on the wound, the patient may be included whether this specie is rare and overwhelmed by the targeted strain (daily swabs will support monitoring the burden of the colonizing specie)
    Patients with local infection due to P. aeruginosa without general signs.
    Patients with local infection due to P. aeruginosa and general signs, and without antibiotic treatment.
    Patients with local infection due to P. aeruginosa and general signs, and with active or non-active antibiotic treatment at the inclusion (randomization and stratification).
    Patients with local infection due to P. aeruginosa and general signs, and with non-active antibiotic treatment during the protocol.
    Patients with local infection due to P. aeruginosa and general signs, and treated with active antibiotic treatment during the protocol must be considered as failure of local treatment.
    Burn wound (grafted or not) or donor site, presenting local signs of infection defined by one or more of the following 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 hemorrhage), 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, bed sore;
    - And/or regarding graft recipient sites: presence of pus, lysis of grafts, necrosis of fat located under the graft.
    Patient treated by povidone-iodine, or any dressing without silver for more than one day before inclusion
    E.4Principal exclusion criteria
    Pregnant or breastfeeding woman
    Undercurrent condition requiring a treatment which may interfere with analysis results: such as high dose of chronic corticotherapy, immunosuppressive medication, oncologic chemotherapy (but antibiotic treatment is not an exclusion criterion, see below).
    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 with a secondary colonization by another species than P. aeruginosa if the colonization level is growing to infection
    Patient considered as part of a vulnerable population as defined by the ICH.
    Patient for whom treatment limitation or withdrawal during study period is considered.
    Patient with general or local sensitization to Sulphonamide (contact dermatitis)
    Patients previously included in this study.
    Patients who have experienced an increase in the SOFA score greater than or equal to 2 during the 48 hours preceding the inclusion day.
    E.5 End points
    E.5.1Primary end point(s)
    Time necessary for a persistent bacteria reduction of two modes (technique of the quarters ) or persistent bacteria eradication relative to D0 adjusted on antibiotic treatment (active on targeted strain) introduced between D1 to D7
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy evaluation performed every day between inclusion and Day 7, then at Day 14.
    E.5.2Secondary end point(s)
    • Same as primary endpoint without adjustment on antibiotic treatment
    • Rate of bacteria reduction
    • Time and rate of improvement or disappearance of clinical signs according to criteria defined by the SFETB guidelines
    • P. aeruginosa Time to bacteria reduction global rate (bacteriological count diminution of 2 modes relative to D0 bacteria count following technique of the quarters), to be evaluated every day from inclusion date to end of trial and at Day 7.
    • Timing and indication of systemic antibiotic treatment (active on targeted strain)
    • Incidence and delay of infection with bacterial species different from the one targeted
    • Incidence and timing of severe sepsis or septic shock attributable to targeted skin infection
    • Reasons for patient’s withdrawal from study (tolerance, graft …)
    • Number of sites cured
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0 to 7, D14 and Day 21
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Switzerland
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit with positive bacterial reduction or eradication
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months27
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months27
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 125
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Next of kin informed consent if patient is not able to give informed consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 125
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-18
    P. End of Trial
    P.End of Trial StatusCompleted
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