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    Summary
    EudraCT Number:2019-002396-34
    Sponsor's Protocol Code Number:APHP180605
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-10-21
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2019-002396-34
    A.3Full title of the trial
    Antibioprophylaxis for excision-graft surgery in burn patient: a multicenter randomized double-blind study
    Antibioprophylaxie pour la chirurgie d'excision-greffe chez le patient brûlé : Etude multicentrique, randomisée et en double aveugle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antibioprophylaxis for excision-graft surgery in burn patient: a multicenter randomized double-blind study
    Antibioprophylaxie pour la chirurgie d'excision-greffe chez le patient brûlé : Etude multicentrique, randomisée et en double aveugle
    A.3.2Name or abbreviated title of the trial where available
    A2B-trial
    A.4.1Sponsor's protocol code numberAPHP180605
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (APHP)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistry
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    B.5.2Functional name of contact pointDRCI Hôpital Saint Louis
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number330144 84 17 33
    B.5.5Fax number330144 84 17 01
    B.5.6E-mailcecile.kedzia@aphp.fr
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namePIPERACILLINE TAZOBACTAM 4 g/0,5 g
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPIPERACILLIN
    D.3.9.3Other descriptive namePIPERACILLIN SODIUM
    D.3.9.4EV Substance CodeSUB03840MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTAZOBACTAM
    D.3.9.3Other descriptive nameTAZOBACTAM SODIUM
    D.3.9.4EV Substance CodeSUB04682MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.IMP: 2
    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 Yes
    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 nameCEFAZOLIN 2g
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEFAZOLIN
    D.3.9.3Other descriptive nameCEFAZOLIN SODIUM
    D.3.9.4EV Substance CodeSUB01107MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    excision-graft surgery in burn patient with a TBSA% between 5% and 40%
    chirurgie d'excision-greffe chez le patient avec une surface corporelle brûlée entre 5% et 40%
    E.1.1.1Medical condition in easily understood language
    excision-graft surgery in burn patient
    chirurgie d'excision-greffe chez le patient brûlé
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10006764
    E.1.2Term Burn of unspecified site, unspecified degree
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    L'objectif principal est d'évaluer l'impact de l'antibioprophylaxie systémique sur les infections postopératoires, la septicémie et la lyse du greffon nécessitant une nouvelle greffe de peau (dans les 7 jours postopératoires) chez les patients brûlés.
    - To evaluate the impact on 90-day mortality
    - To evaluate the impact on antibiotic consumption
    -To evaluate the impact on the duration of hospitalization until complete healing (> 95% total burn surface area)
    - To evaluate the impact on the duration of hospitalization living without antibiotic therapy
    - To evaluate the impact on colonization by multidrug-resistant bacteria during hospital stay
    E.2.2Secondary objectives of the trial
    - Évaluer l'impact sur la mortalité à 90 jours
    - Évaluer l'impact sur la consommation d'antibiotiques
    -Évaluer l'impact sur la durée de l'hospitalisation jusqu'à la guérison complète (> 95 % de la surface totale des brûlures).
    - Évaluer l'impact sur la durée de l'hospitalisation en l'absence d'antibiothérapie
    - Évaluer l'impact sur la colonisation par des bactéries multirésistantes lors d'un séjour à l'hôpital.
    - Évaluer l'impact sur la mortalité à 90 jours
    - Évaluer l'impact sur la consommation d'antibiotiques
    -Évaluer l'impact sur la durée de l'hospitalisation jusqu'à la guérison complète (> 95 % de la surface totale des brûlures).
    - Évaluer l'impact sur la durée de l'hospitalisation en l'absence d'antibiothérapie
    - Évaluer l'impact sur la colonisation par des bactéries multirésistantes lors d'un séjour à l'hôpital.
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Major patient over 18 years and less than 80 years old
    - Burned patients requiring at least one excision-graft surgery
    - burn TBSA between 5 and 40%
    - Signed informed consent or inclusion under the emergency provisions of the law (article L1122-1-2 of the CSP)
    E.3Principal inclusion criteria
    - Patient majeur âgé de plus de 18 ans et de moins de 80 ans
    - Brûlés nécessitant au moins une intervention chirurgicale d'excision-greffe
    - SCB entre 5 et 40 %.
    - Consentement éclairé signé ou inclusion en vertu des dispositions d'urgence de la loi (article L1122-1-2 du DSP)
    - Proven severe allergy to cephalosporin or piperacilline-tazobactam or any other antibacterial agent of the penicillin class
    - History of severe allergic reaction to any other beta-lactam (eg cephalosporins, monobactams or carbapenems).
    - Patient on antibiotic therapy at the time of inclusion
    - Pregnant or breast-feeding patient
    - Patient not covered by the social security
    - Patient transferred from another burn Unit
    - Patient participant in investigational competitive medicinal product study on the primary endpoint
    - Patient under guardianship
    - Patient under curatorship
    E.4Principal exclusion criteria
    -Allergie sévère prouvée à la céphalosporine ou à la pipéracilline-tazobactam ou à tout autre agent antibactérien de la classe des pénicillines.
    - Antécédents de réaction allergique grave à tout autre bêta-lactame (p. ex. céphalosporines, monobactames ou carbapénèmes).
    - Patient sous antibiothérapie au moment de l'inclusion
    - Patiente enceinte ou allaitante
    - Patient non couvert par la sécurité sociale
    - Patient transféré d'une autre unité de grands brûlés
    - Patient participant à une étude expérimentale sur un médicament compétitif sur le critère d'évaluation principal
    - Patient sous tutelle
    - Patient sous curatelle
    Post-operative infection defined as Post-operative sepsis and/or surgical site infection, and/or graft lysis requiring a new graft within 7 days after surgery.
    E.5 End points
    E.5.1Primary end point(s)
    Infection post-opératoire définie comme une septicémie post-opératoire et/ou une infection du site opératoire, et/ou une lyse du greffon nécessitant une nouvelle greffe dans les 7 jours suivant l'intervention.
    within 7 days after surgery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    dans les 7 jours suivant l'intervention.
    90 days mortality
    - Skin graft lysis requiring a new graft procedure
    - Postoperative bacteremia (within 48 hours of surgery)
    - Post operative sepsis
    - Post operative surgical site infection
    - Number of days of hospitalization until complete healing (> 95% total burn surface area)
    - Number of hospitalization days living without antibiotic therapy at D28 and Day 90
    - Multiresistant bacteria colonization of infection at D28 and Day 90
    E.5.2Secondary end point(s)
    - Mortalité à J90
    - Lyse d'une greffe de peau nécessitant une nouvelle procédure de greffe
    - Bactériémie postopératoire (dans les 48 heures suivant l'intervention)
    - Sepsis postopératoire
    - Infection postopératoire du site opératoire
    - Nombre de jours d'hospitalisation jusqu'à la guérison complète (> 95 % de la surface totale des brûlures)
    - Nombre de jours d'hospitalisation sans antibiothérapie à J28 et au Jour 90
    - Colonisation bactérienne multirésistante à J28 et Jour 90
    90 days mortality
    - Skin graft lysis requiring a new graft procedure
    - Postoperative bacteremia (within 48 hours of surgery)
    - Post operative sepsis
    - Post operative surgical site infection
    - Number of days of hospitalization until complete healing (> 95% total burn surface area)
    - Number of hospitalization days living without antibiotic therapy at D28 and Day 90
    - Multiresistant bacteria colonization of infection at D28 and Day 90
    E.5.2.1Timepoint(s) of evaluation of this end point
    Mortalité à J90
    - Lyse d'une greffe de peau nécessitant une nouvelle procédure de greffe
    - Bactériémie postopératoire (dans les 48 heures suivant l'intervention)
    - Sepsis postopératoire
    - Infection postopératoire du site opératoire
    - Nombre de jours d'hospitalisation jusqu'à la guérison complète (> 95 % de la surface totale des brûlures)
    - Nombre de jours d'hospitalisation sans antibiothérapie à J28 et au Jour 90
    - Colonisation bactérienne multirésistante à J28 et Jour 90
    Mortalité à J90
    - Lyse d'une greffe de peau nécessitant une nouvelle procédure de greffe
    - Bactériémie postopératoire (dans les 48 heures suivant l'intervention)
    - Sepsis postopératoire
    - Infection postopératoire du site opératoire
    - Nombre de jours d'hospitalisation jusqu'à la guérison complète (> 95 % de la surface totale des brûlures)
    - Nombre de jours d'hospitalisation sans antibiothérapie à J28 et au Jour 90
    - Colonisation bactérienne multirésistante à J28 et Jour 90
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) No
    E.7.1.1First administration to humans No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    Dernier suivi du dernier inclus
    Dernier suivi du dernier inclus
    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 months51
    E.8.9.1In the Member State concerned days
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 106
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state506
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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