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    Summary
    EudraCT Number:2018-001709-10
    Sponsor's Protocol Code Number:P170924J
    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:2018-07-11
    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 number2018-001709-10
    A.3Full title of the trial
    I-MICRO: Ilomedine in the treatment of septic shock with persistence of microperfusion disorders: Multicenter randomized and controlled double-blind study.
    I-MICRO : Ilomedine dans le traitement du choc septique avec persistance de troubles de la microperfusion : Etude multicentrique randomisée et contrôlée en double aveugle.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ilomedin for treatment of septic shock with persistent microperfusion defects
    Ilomédine dans le traitement du choc septique avec persistence de troubles de la microperfusion
    A.3.2Name or abbreviated title of the trial where available
    I-MICRO
    A.4.1Sponsor's protocol code numberP170924J
    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 (AP-HP)
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailelodie.lemadre@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.2.1.1.1Trade name Ilomédine
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER HEALTHCARE
    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 nameIlomédine
    D.3.2Product code B01AC11
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 infusion
    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
    Ilomedin: Cardiology - Angeiology - Vasodilators and anti-ischemic drugs: Severe ischemia: route of injection (Prostaglandin analogs: iloprost)
    Ilomedine : Cardiologie - Angéiologie - Vasodilatateurs et anti-ischémiques : Ischémie sévère : voie injectable (Analogues de la prostaglandine : iloprost)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    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
    Primary objective: to assess the effect of Ilomedin infusion on organ function in septic shock patients with persistent peripheral hypoperfusion despite macrohemodynamic parameter optimization

    Secondary objectives:
    to assess the effect of Ilomedin on:
    - the risk of death during the first 28 days after randomization
    - the impact on organ support (i.e. renal replacement therapy, vasopressor treatment, mechanical ventilation)
    - organ failure during the first 7 days after randomization (evaluated with the SOFA score)
    - safety of the drug and potential side-effects of Ilomedin
    Objectif principal: évaluer l'effet de la perfusion d'Ilomedin sur la fonction d'un organe chez des patients atteints d'un choc septique avec hypoperfusion périphérique persistante malgré l'optimisation des paramètres macro-hémodynamiques

    Objectifs secondaires :
    évaluer l'effet d'Ilomedin sur:
    - le risque de décès au cours des 28 premiers jours après la randomisation
    - l'impact sur le soutien des organes (c'est-à-dire la thérapie de remplacement rénal, le traitement vasopresseur, la ventilation mécanique)
    - défaillance d'organe au cours des 7 premiers jours après la randomisation (évaluée avec le score SOFA)
    - innocuité du médicament et effets secondaires potentiels d'Ilomedin
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria :
    *Patients over 18 years of age
    *Signed informed consent or inclusion under the emergency provisions of the law (Article L1122 -1-3 of the PHC/modified by order n°2016-800 of June 16 2016 - art. 2)
    *Patients in septic shock defined by the third international definition :
    - suspected or proven infection,
    - and organ dysfunction defined by an acute change in total SOFA score >or=2
    - and serum lactate level > 2 mmol/L despite standard of care hemodynamic optimization (*see check list).
    - and persistent hypotension requiring vasopressor treatment to maintain mean arterial pressure > 65 mmHg despite standard of care hemodynamic optimization (*see checklist).
    - and persistence of peripheral hypoperfusion (mottling score > or = 2 and/or finger skin recoloration time > 3sec, and/or knee skin recoloration time > 4sec)
    - within 6 to 24 hours after norepinephrine onset
    Critère d'inclusion :
    * Patients de plus de 18 ans
    * Consentement éclairé signé ou inclus dans les dispositions d'urgence de la loi (Article L1122-1-3 du PHC / modifié par arrêté n ° 2016-800 du 16 juin 2016 - article 2)
    * Patients en choc septique définis par la troisième définition internationale:
    - infection suspectée ou prouvée,
    - et le dysfonctionnement d'organe défini par un changement aigu du score SOFA total> ou = 2
    - et taux de lactate sérique> 2 mmol / L malgré une optimisation hémodynamique standard (* voir liste de contrôle).
    - et une hypotension persistante nécessitant un traitement vasopresseur pour maintenir une pression artérielle moyenne> 65 mmHg malgré une optimisation hémodynamique standard (* voir liste de contrôle).
    - et persistance de l'hypoperfusion périphérique (score de marbrure> ou = 2 et / ou temps de recoloration de la peau du doigt> 3sec, et / ou temps de recoloration de la peau du genou> 4sec)
    - dans les 6 à 24 heures suivant le début de la norépinéphrine
    E.4Principal exclusion criteria
    Non inclusion criteria :
    - refusal to participate in the study
    - pregnancy, breastfeeding
    - hypersensitivity to Ilomedin or to any of the excipients.
    - conditions where the hemorrhagic risk may be increased due to the effects of Ilomedin on platelets (i.e., evolving hemorrhage, trauma, intracranial hemorrhage, active gastric ulcer).
    - platelet count < 30000 /mm3
    - unstable angina.
    - severe cardiac rhythm disorders since Norepinephrine onset (ventricular fibrillation or tachycardia)
    - severe hypoxemia (PaO2/FiO2 <100)
    - lack of social Insurance
    - persons deprived of liberty
    Critères de non inclusion
    - refus de participer à l'étude
    - grossesse, allaitement maternel
    - hypersensibilité à l'ilomédine ou à l'un des excipients.
    - les conditions dans lesquelles le risque hémorragique peut être augmenté en raison des effets de l'ilomédine sur les plaquettes (c.-à-d., hémorragie évolutive, traumatisme, hémorragie intracrânienne, ulcère gastrique actif).
    - nombre de plaquettes <30000 / mm3
    - une angine instable.
    - troubles sévères du rythme cardiaque depuis l'apparition de la norépinéphrine (fibrillation ventriculaire ou tachycardie)
    - hypoxémie sévère (PaO2 / FiO2 <100)
    - manque d'assurance sociale
    - les personnes privées de liberté
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome:
    Delta SOFA (sequential organ failure assessment) score between randomization and day-7).

    Secondary outcomes :
    - mean SOFA score during the first 7 days after randomization
    - number of survival days outside ICU in the 28 days post randomization
    - number of ventilation-free survival days in the 28 days post randomization
    - number of renal replacement therapy-free survival days in the 28 days post randomization
    - number of vasopressor-free survival days in the 28 days post randomization
    -mottling score at day 1 after randomizationRésultat primaire:
    Le score Delta SOFA (évaluation séquentielle des défaillances d'organes) entre la randomisation et le jour 7).

    Résultats secondaires
    - score SOFA moyen au cours des 7 premiers jours après la randomisation
    - nombre de jours de survie en dehors des soins intensifs dans les 28 jours suivant la randomisation
    - nombre de jours de survie sans ventilation dans les 28 jours suivant la randomisation
    - nombre de jours de survie sans traitement rénal substitutif dans les 28 jours suivant la randomisation
    - nombre de jours de survie sans vasopresseur dans les 28 jours suivant la randomisation
    -mottling score au jour 1 après la randomisation
    Critère d'évaluation primaire :
    Le score Delta SOFA (évaluation séquentielle des défaillances d'organes) entre la randomisation et le jour 7).

    Critère d'évaluation secondaires :
    - score SOFA moyen au cours des 7 premiers jours après la randomisation
    - nombre de jours de survie en dehors des soins intensifs dans les 28 jours suivant la randomisation
    - nombre de jours de survie sans ventilation dans les 28 jours suivant la randomisation
    - nombre de jours de survie sans traitement rénal substitutif dans les 28 jours suivant la randomisation
    - nombre de jours de survie sans vasopresseur dans les 28 jours suivant la randomisation
    -mottling score au jour 1 après la randomisation
    E.5.2Secondary end point(s)
    - score SOFA moyen au cours des 7 premiers jours après la randomisation
    - nombre de jours de survie en dehors des soins intensifs dans les 28 jours suivant la randomisation
    - nombre de jours de survie sans ventilation dans les 28 jours suivant la randomisation
    - nombre de jours de survie sans traitement rénal substitutif dans les 28 jours suivant la randomisation
    - nombre de jours de survie sans vasopresseur dans les 28 jours suivant la randomisation
    -mottling score au jour 1 après la randomisation
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.7.1.3.1Other trial type description
    Phase III: multicenter, superiority, double-blind, randomized, controlled : other indication
    Phase III : multicentrique, supériorité, double-aveugle, randomisée, contrôlée : autre indication
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned17
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    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: 236
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-07-11. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state236
    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 Decision2018-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
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