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    Summary
    EudraCT Number:2015-003972-64
    Sponsor's Protocol Code Number:2015-09
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-11
    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 number2015-003972-64
    A.3Full title of the trial
    Plasma and tissue pharmacokinetics of amikacin administrated by dressing impregnated in burns patients
    Etude de la pharmacocinétique plasmatique et tissulaire de l’amikacine après administration par pansement imprégné chez le patient brulé
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Plasma and tissue pharmacokinetics of amikacin administrated by dressing impregnated in burns patients
    Etude de la pharmacocinétique plasmatique et tissulaire de l’amikacine après administration par pansement imprégné chez le patient brulé
    A.3.2Name or abbreviated title of the trial where available
    AMIKACINE
    A.4.1Sponsor's protocol code number2015-09
    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 MARSEILLE
    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 supportASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJean-Olivier ARNAUD
    B.5.2Functional name of contact pointDirector
    B.5.3 Address:
    B.5.3.1Street Address80 rue brochier
    B.5.3.2Town/ citymarseille
    B.5.3.3Post code13005
    B.5.3.4CountryFrance
    B.5.4Telephone number0491382747
    B.5.5Fax number0491381479
    B.5.6E-maildrci@ap-hm.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.2.1.1.1Trade name AMIKACINE MYLAN 1 g
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN S.A.S.
    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.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMIKACIN SULFATE
    D.3.9.1CAS number 39831-55-5
    D.3.9.2Current sponsor codeamikacine
    D.3.9.3Other descriptive nameamikacine
    D.3.9.4EV Substance CodeSUB00444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    burns patients
    E.1.1.1Medical condition in easily understood language
    burns patients
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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
    describe the plasma and tissue pharmacokinetics of amikacin after dermal administration and impregnated dressing to estimate the pharmacokinetic parameters and their variability in a burned population.
    décrire la pharmacocinétique plasmatique et tissulaire de l’amikacine après administration cutanée par pansement imprégné et d’estimer les paramètres pharmacocinétiques et leur variabilité au sein d’une population de patients brûlés.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to assess on the one hand the relationship between the effectiveness of treatment and the concentration of antibiotic at the site of tissue infection, and on the other hand to assess the relationship between plasma concentration and the toxicity found of this treatment.
    Les objectifs secondaires sont d’une part d’évaluer la relation entre l’efficacité du traitement et la concentration d’antibiotique tissulaire au site de l’infection, et d’autre part d’évaluer la relation entre la concentration plasmatique retrouvée et la toxicité du traitement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age minimal 18 years old.
    male or female
    Burn skin infection supported by percutaneous administration of amikacin. Presence of positive local signs of bacterial cutaneous infection meeting the criteria as defined by the French Society of Brulology (SFB):
    Presence of a local or locoregional inflammatory reaction
    and or
    o an unfavorable and unexpected local evolution
    at the burns: presence of pus, fast debridement, appearance of black spots (necrosis or haemorrhage), unexplained conversion of a superficial lesion to a deep lesion (> 48h)
    at the level of engraftment: presence of pus, unexplained healing delay, pressure ulcer
    at the level of the grafts: presence of pus, lysis of the grafts, necrosis of the fat located under the graft
    at the level of healed areas: impetigo, lysis of healed areas.
    Presence of a local or locoregional inflammatory reaction
    and or an unfavorable and unexpected local evolution
    At the level burns: presence of pus, fast debridement, appearance of black spots (necrosis or haemorrhage), unexplained conversion of a superficial lesion to a deep lesion (> 48h)
    at the level of engraftment: presence of pus, unexplained healing delay, pressure ulcer
    at the level of the grafts: presence of pus, lysis of the grafts, necrosis of the fat located under the graft
    at the level of healed areas: impetigo, lysis of healed areas.
    subject benefiting from social security
    Subject agreeing to participate in the study and having signed an informed consent
    Subject mastering the French language.
    Age : supérieur à 18 ans.
    Homme ou femme
    Infection cutanée de brûlure prise en charge par administration percutanée d’amikacine. Présence de signes locaux positifs d’infection cutanée bactérienne répondant aux critères tels que définis par la Société Française de Brûlologie (SFB) :
    o Présence d’une réaction inflammatoire locale ou loco-régionale
    et/ou
    o une évolution locale défavorable et inattendue :
    au niveau des brûlures : présence de pus, détersion rapide, apparition de taches noirâtres (nécrose ou hémorragie), conversion inexpliquée d’une lésion superficielle en lésion profonde (>48h)
    au niveau des prises de greffe : présence de pus, retard de cicatrisation inexpliqué, escarre
    au niveau des greffes : présence de pus, lyse des greffes, nécrose de la graisse située sous la greffe
    au niveau des zones cicatrisées : impétigo, lyse des zones guéries.
    Sujet bénéficiant d’une couverture sociale
    Sujet acceptant de participer à l’étude et ayant signé un consentement éclairé
    Sujet maîtrisant la langue française.
    E.4Principal exclusion criteria
    Minor subject or pregnant or breastfeeding woman
    Subject deprived of liberty
    Subject under guardianship or guardianship
    Subject does not have social security
    Subject not accepting to participate in the study
    subject having
    Allergy to amikacin or other aminoglycoside antibiotic
    Myasthenia gravis
    Subject withdrawing consent during the study
    Patients receiving intravenous aminoglycoside during local treatment.
    Sujet mineur ou femme enceinte ou allaitante
    Sujet privé de liberté
    Sujet sous curatelle ou sous tutelle
    Sujet ne disposant pas de couverture sociale
    Sujet n’acceptant pas de participer à l’étude
    sujet ayant
    Allergie à l’amikacine ou à un autre antibiotique de la famille des aminosides
    Myasthénie grave
    Sujet retirant son consentement au cours de l’étude
    Patients recevant pendant le traitement local des aminosides par voie intra veineuse.
    E.5 End points
    E.5.1Primary end point(s)
    bacteriological samples; decrease in concentration at the sampling sites (cutaneous biopsy or swab), no appearance of bacterial resistance (on the antibiograms performed).
    prélèvements bactériologiques; diminution de la concentration sur les sites de prélèvement (biopsie cutanée ou écouvillon), absence d’apparition de résistance bactérienne (sur les antibiogrammes réalisés).
    E.5.1.1Timepoint(s) of evaluation of this end point
    21 months
    E.5.2Secondary end point(s)
    absence of surgical revision (no new skin graft), scarring (note the time to heal),
    absence de reprise chirurgicale (pas de nouvelle greffe de peau), cicatrisation (noter le délai de cicatrisation),
    E.5.2.1Timepoint(s) of evaluation of this end point
    21 months
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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 months21
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    patients in intensive care
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    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 Decision2019-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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