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    Summary
    EudraCT Number:2018-003496-36
    Sponsor's Protocol Code Number:69HCL17_0843
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-06
    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 number2018-003496-36
    A.3Full title of the trial
    Dosage optimization of piperacillin/tazobactam in ICU patients based on therapeutic drug monitoring of amikacin - OPTIMA
    Optimisation du dosage de pipéracilline tazobactam en fonction du monitoring thérapeutique de l’amikacine chez les patients de réanimation - OPTIMA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dosage optimization of piperacillin/tazobactam in ICU patients based on therapeutic drug monitoring of amikacin - OPTIMA
    Optimisation du dosage de pipéracilline tazobactam en fonction du monitoring thérapeutique de l’amikacine chez les patients de réanimation - OPTIMA
    A.3.2Name or abbreviated title of the trial where available
    OPTIMA
    A.4.1Sponsor's protocol code number69HCL17_0843
    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 SponsorHospices Civils de Lyon
    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 supportHospices Civils de Lyon
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointElisa Letellier
    B.5.3 Address:
    B.5.3.1Street Address3 quai des Célestins
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number+330472406837
    B.5.5Fax number+330472115190
    B.5.6E-maildrci_promo@chu-lyon.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 nameamikacin
    D.3.4Pharmaceutical form Powder 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 INNAMIKACIN
    D.3.9.1CAS number 37517-28-5
    D.3.9.4EV Substance CodeSUB05431MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number250 to 1000
    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.2.1.2Country 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 namepiperacillin/tazobactam
    D.3.4Pharmaceutical form Powder 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 INNpiperacillin
    D.3.9.3Other descriptive namePIPERACILLIN SODIUM
    D.3.9.4EV Substance CodeSUB03840MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtazobactam
    D.3.9.3Other descriptive nameTAZOBACTAM
    D.3.9.4EV Substance CodeSUB10849MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number250 to 500
    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
    sepsis or septic shock
    sepsis ou choc septique
    E.1.1.1Medical condition in easily understood language
    sepsis or septic shock
    sepsis ou choc septique
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10040047
    E.1.2Term Sepsis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10040070
    E.1.2Term Septic shock
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Measure the association between the pharmacokinetics parameters of piperacillin, tazobactam (plasma clearance and volume of distribution) and those of amikacine in patients treated by the association for septic symdrome in Intensive care unit.
    Mesurer l'association entre les paramètres pharmacocinétiques de la pipéracilline, du tazobactam (clairance plasmatique et volume plasmatique) et ceux de l'amikacine chez des patients traités par l'association pour un syndrome septique en réanimation.
    E.2.2Secondary objectives of the trial
    - Elaboration of population pharmacokinetics models of piperacillin, tazobactam, permitting the estimation of pharmacokinetics parameters of these molecules in this population.
    - Evaluation of the influence of covariates other than those relating to the pharmacokinetic of amikacin on the pharmacokinetic parameters of piperacillin and tazobactam.
    - Elaboration de modèles pharmacocinétiques de population de la pipéracilline, du tazobactam permettant l’estimation des paramètres pharmacocinétique de ces molécules dans cette population.
    - Evaluation de l’influence de covariables autres que celles relatives à la pharmacocinétique de l’amikacine sur les paramètres pharmacocinétiques de la pipéracilline et du tazobactam.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient, male or female, over the age of 18, hospitalized in the critical care unit of the Lyon-Sud Hospital Center.
    - Patient presenting a clinical picture of sepsis or severe sepsis defined by the latest international recommendations.
    - Patient to be treated with amikacin + piperacillin / tazobactam.
    - Patient affiliated to a social security scheme,
    - having agreed to participate in the study
    - Patient, homme ou femme, âgé de plus de 18 ans, hospitalisé dans le service de soins critiques du centre hospitalier Lyon-Sud.
    - Patient présentant un tableau de sepsis ou sepsis sévère défini par les dernières recommandations internationales.
    - Patient devant être traité par l’association amikacine + pipéracilline/tazobactam.
    - Patient affilié à un régime de sécurité sociale,
    - ayant accepté de participer à l’étude
    E.4Principal exclusion criteria
    - Minor patient.
    - Patient participating in another research potentially interfering (investigator's judgment) with the results of this study.
    - Refusal of the patient to participate in the study.
    - Major patient protected under the terms of the law (Public Health Code).
    - Patient with a known history of hypersensitivity or contraindication to amikacin, piperacillin or tazobactam.
    - Patient known to have previously received piperacillin / tazobactam or amikacin prior to inclusion of the patient.
    - Patient treated at the time of inclusion by extra-renal cleansing techniques.
    - Patient mineur.
    - Patient participant à une autre recherche pouvant interférer (jugement de l’investigateur) avec les résultats de la présente étude.
    - Refus du patient de participer à l’étude.
    - Patient majeur protégé selon les termes de la loi (Code de la santé Publique).
    - Patient ayant des antécédents connus d’hypersensibilité ou de contre-indication à l’amikacine, la pipéracilline ou au tazobactam.
    - Patient connu comme ayant déjà reçu l’association pipéracilline/tazobactam ou de l’amikacine avant l’inclusion du patient.
    - Patient traité au moment de l’inclusion par des techniques d’épuration extra-rénale.
    E.5 End points
    E.5.1Primary end point(s)
    - Patient mineur.
    - Patient participant à une autre recherche pouvant interférer (jugement de l’investigateur) avec les résultats de la présente étude.
    - Refus du patient de participer à l’étude.
    - Patient majeur protégé selon les termes de la loi (Code de la santé Publique).
    - Patient ayant des antécédents connus d’hypersensibilité ou de contre-indication à l’amikacine, la pipéracilline ou au tazobactam.
    - Patient connu comme ayant déjà reçu l’association pipéracilline/tazobactam ou de l’amikacine avant l’inclusion du patient.
    - Patient traité au moment de l’inclusion par des techniques d’épuration extra-rénale.
    - Patient mineur.
    - Patient participant à une autre recherche pouvant interférer (jugement de l’investigateur) avec les résultats de la présente étude.
    - Refus du patient de participer à l’étude.
    - Patient majeur protégé selon les termes de la loi (Code de la santé Publique).
    - Patient ayant des antécédents connus d’hypersensibilité ou de contre-indication à l’amikacine, la pipéracilline ou au tazobactam.
    - Patient connu comme ayant déjà reçu l’association pipéracilline/tazobactam ou de l’amikacine avant l’inclusion du patient.
    - Patient traité au moment de l’inclusion par des techniques d’épuration extra-rénale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    H0 (Baseline), H1 (1 hour after the beginning of the amikacin perfusion), H5, H7, H24
    H0 (inclusion), H1 (1 heure après le début de la perfusion d'amikacin), H5, H7, H24
    E.5.2Secondary end point(s)
    - Objective function of the pharmacokinetic models tested (likelihood ratio test).
    - Value of correlation coefficient β binding a covariate to a pharmacokinetic parameter (Wald test)
    - Fonction objectif des modèles pharmacocinétiques testés (Test du rapport des vraisemblances).
    - Valeur du coefficient de corrélation β liant une covariable à un paramètre pharmacocinétique (Test de Wald)
    E.5.2.1Timepoint(s) of evaluation of this end point
    H0 (Baseline), H1 (1 hour after the beginning of the amikacin perfusion), H5, H7, H24
    H0 (inclusion), H1 (1 heure après le début de la perfusion d'amikacin), H5, H7, H24
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Last visit of the last subject undergoing the trial
    Dernière visite du dernier patient participant à la recherche
    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 months6
    E.8.9.1In the Member State concerned days24
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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
    The management recommendations for serious infections recommend the implementation of antibiotic therapy within one hour of the clinical diagnosis. No possibility of consent by the patient himself is a usual case in intensive care.
    Les recommandations de prise en charge des infections graves recommandent la mise en œuvre de l’antibiothérapie dans l’heure suivant le diagnostic. La non possibilité de consentement par le patient lui-même est un cas habituel en réanimation.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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
    Aucun
    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 Decision2019-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
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