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    Summary
    EudraCT Number:2020-002671-34
    Sponsor's Protocol Code Number:PI20208430057
    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:2020-07-06
    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 number2020-002671-34
    A.3Full title of the trial
    Comparison of Landiolol versus standard of care for prevention of mortality in patients hospitalized for a septic shock with hypercontractlity: an open label prospective randomized study
    Comparaison de la prévention de la mortalité entre le Landiolol et la prise en charge standard des patients hospitalisés avec choc septique et hyperkinétique : étude ouverte prospective randomisée
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Landiolol versus standard of care for prevention of mortality in patients hospitalized for a septic shock with hypercontractlity: an open label prospective randomized study
    Comparaison de la prévention de la mortalité entre le Landiolol et la
    prise en charge standard des patients hospitalisés avec choc septique et
    hyperkinétique : étude ouverte prospective randomisée
    A.3.2Name or abbreviated title of the trial where available
    Hyper-Betashock
    Hyper-Betashock
    A.4.1Sponsor's protocol code numberPI20208430057
    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 SponsorCHU Amiens-Picardie
    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 supportDGOS (PHRC N 2019)
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportAmomed Pharma SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Amiens-Picardie
    B.5.2Functional name of contact pointPoject Manager
    B.5.3 Address:
    B.5.3.1Street AddressDRCI, CHU Amiens-Picardie
    B.5.3.2Town/ cityAmiens
    B.5.3.3Post code80054
    B.5.3.4CountryFrance
    B.5.6E-mailmattoug.salah@chu-amiens.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 RAPIBLOC 300 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAMOMED PHARMA GMBH
    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 nameLandiolol
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrauterine 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    septic shock with hypercontractlity
    choc septique et hyperkinétique
    E.1.1.1Medical condition in easily understood language
    septic shock with hypercontractlity
    choc septique et battement du cœur très rapide
    E.1.1.2Therapeutic area Not possible to specify
    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
    to demonstrate that the reduction of heart rate using the landiolol may
    improve the mortality of septic shock patients with tachycardia and
    hypercontractility in comparison to control group at day 28
    Démontrer que le landiolol dans l'état de choc hyperkinétique en
    ralentissant la fréquence cardiaque peut diminuer la mortalité à
    28 jours
    E.2.2Secondary objectives of the trial
    Secondary objectives are to demonstrate that the reduction of heart
    rate using the landiolol in comparison to standard of care may:
    - Reduce tachycardia
    - Reduce hypercontractility
    - Reduce shock duration
    - Reduce the length of stay
    - Reduce the multi organ failure
    - Reduce the incidence of atrial fibrillation
    Les objectifs secondaires sont de démontrer que la réduction de la
    fréquence cardiaque en utilisant le landiolol par rapport à une prise en
    charge standard sans ce traitement peut :
    - Réduire la fréquence cardiaque
    - Réduire l'hyperkinésie
    - Réduire la durée du choc
    - Réduire la durée d'hospitalisation
    - Réduire les atteintes viscérales
    - Réduire l'incidence de l'arythmie par fibrillation auriculaire (TAC/FA)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The aim of this study will be to analyse hemodynamic of included patients using echocardiography. The objective is to assess the effect of landiolol compared to standard of care on cardiac function. Full echocardiography will be performed at baseline and during the follow-up at H1, H3, H6 and H12.
    Le but de cette étude sera d'analyser l'hémodynamique des patients
    inclus en utilisant l'échocardiographie. L'objectif est d'évaluer l'effet du
    landiolol par rapport à une prise en charge standard sur la fonction
    cardiaque. Une échocardiographie complète sera réalisée à la baseline
    et pendant le suivi à H1, H3, H6 et H12.
    E.3Principal inclusion criteria
    - Age ≥ 18 years old
    - Patient admitted for a septic shock (according to the SEPSIS3
    definition:
    sepsis with persisting hypotension (MAP<65mmHg or SAP <90mmHg)
    requiring vasopressors to maintain MAP>65mmHg and having a serum
    lactate level >2 mmol/L
    - Patient who received at least 30ml/kg of fluid and absence of fluid
    responsiveness
    - Left ventricular ejection fraction >65% (visual or Simpson method
    using echocardiography)
    - Tachycardia >100 bpm in sinus rhythm with a MAP > or = 65mmHg for
    more than 1 hour
    - Patient receiving invasive mechanical ventilation
    - Patient de plus de 18 ans
    - Admis pour choc septique
    - Ayant reçu 30 ml/kg de remplissage vasculaire
    - Avec fraction d'éjection > 65%
    - Tachycardie > 100/ mn avec pression artérielle moyenne supérieure
    ou égale à 65 mmHg depuis plus d'une heure
    - Patient intubé ventilé bien adapté à son respirateur, sédaté analgésié
    E.4Principal exclusion criteria
    - Patients with inclusion criteria already present for more than 36 hours
    - Patient treated with Dobutamine, adrenaline or isoprenaline
    - Patient currently treated with beta blockers (previous home
    betablocker treatment is not an exclusion criteria)
    - Supra ventricular (atrial fibrillation or flutter) or ventricular
    arrhythmias
    - Patients with any form of cardiac pacing
    - Sick sinus syndrome
    - Severe atrioventricular (AV) nodal conductance disorders (without
    pacemaker): 2nd or 3rd degree AV block
    - Known pulmonary hypertension
    - ScVO2 <70%
    - Moribund
    - Cardiac arrest
    - Non-treated phaeochromocytoma
    - Acute asthmatic attack
    - Pregnant or breastfeeding woman
    - Hypersensitivity to the active substance or to any of the excipients
    - Patient déjà sous béta bloquants
    - TAC/FA ou TV
    - Présence d'un pace maker
    - Bloc auriculo ventriculaire
    - HTAP connue
    - ScVO2<70%
    - Phéochromocytome non traité
    - Asthme sévère décompensé
    - Hypersensibilité à la substance active ou à l'un des excipients
    E.5 End points
    E.5.1Primary end point(s)
    mortality at day 28
    mortalité à 28 jours
    E.5.1.1Timepoint(s) of evaluation of this end point
    at day 28
    à 28 jours
    E.5.2Secondary end point(s)
    - Number of patients that achieved a reduction of heart rate equal or higher to 20% of the initial HR with landiolol
    - Number of days receiving catecholamines
    - Number of days receiving mechanical ventilation
    - Length of stay in ICU and hospital
    - SOFA score at inclusion and day 1, 2, 3, 7, 14 and 28 following the
    inclusion
    - Number of patients developing atrial fibrillation of flutter during the
    first three days
    - Hospital mortality
    - Safety: number of episodes of bradycardia (<50 bpm) or LVEF <
    45% or MAP <65mmHg requiring an increase of Norepinephrine >
    40% during the entire period of treatment with the landiolol
    - Unexpected cardiac arrest
    - Nombre de patients avec fréquence cardiaque réduite de plus de
    20%
    - Nombre de jour sous ventilation mécanique
    - Nombre de jour sous catécholamines
    - Durée d'hospitalisation en réanimation et à l'hôpital
    - SOFA aux jours J1,2,3,7,14,28
    - Nombre de patients en TAC/FA ou flutter auriculaire
    - Mortalité en réanimation et hospitalière
    - Nombre d'épisodes de bradycardie (<50 /mn) de chute tensionnelle (PAM<65 mmHg) nécessitant le recours à l'augmentation
    de plus de 40% de noradrénaline, fraction d'éjection<45%
    - Arrêt cardiaque
    E.5.2.1Timepoint(s) of evaluation of this end point
    at day 28
    à 28 jours
    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 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 Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    prise en charge standard
    standard of care
    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 concerned25
    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
    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 months37
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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
    unconscious patient
    patient inconscient
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state360
    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
    Néant
    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 Decision2020-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-04
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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