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    Summary
    EudraCT Number:2016-004222-42
    Sponsor's Protocol Code Number:2015_65
    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:2017-09-28
    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 number2016-004222-42
    A.3Full title of the trial
    Validation of the efficiency of repurposed drugs on the basis of their cellular transcriptomic signature, antagonist to that of the influenza A infection.
    Validation de l’efficacité antigrippale de molécules repositionnées sur la base de leur capacité à inverser la signature transcriptomique des cellules infectées par le virus Influenza A.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Re-evaluation of Etilefrine and Diltiazem combined with Oseltamivir (Tamiflu) in the treatment of seasonal flu.
    Ré-évaluation de l'Etiléfrine et du Diltiazem associés à l'Oseltamivir (Tamiflu) dans le traitement de la grippe saisonnière.
    A.3.2Name or abbreviated title of the trial where available
    FLUNEXT
    A.4.1Sponsor's protocol code number2015_65
    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 SponsorCentre Hospitalier Régional Universitaire de Lille
    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 supportCHRU de Lille
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDépartement de la Recherche en Santé
    B.5.2Functional name of contact pointAmélie LECOCQ
    B.5.3 Address:
    B.5.3.1Street Address6 rue du professeur Laguesse
    B.5.3.2Town/ cityLille
    B.5.3.3Post code59037
    B.5.3.4CountryFrance
    B.5.4Telephone number00330320444145
    B.5.5Fax number00330320445711
    B.5.6E-maildrc@chru-lille.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 Effortil
    D.2.1.1.2Name of the Marketing Authorisation holderSCS Boehringer Ingelheim Comm. V
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameEtilefrine
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETILEFRINE
    D.3.9.1CAS number 709-55-7
    D.3.9.4EV Substance CodeSUB07303MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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.2.1.1.1Trade name Tildiem
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameDiltiazem
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDILTIAZEM
    D.3.9.1CAS number 42399-41-7
    D.3.9.4EV Substance CodeSUB07148MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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: 3
    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 Tamiflu
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire ROCHE
    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 nameOseltamivir
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOSELTAMIVIR
    D.3.9.1CAS number 196618-13-0
    D.3.9.4EV Substance CodeSUB03553MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 placeboOral liquid
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Seasonal Flu due to Influenza A virus.
    La grippe saisonnière par infection au virus Influenza A.
    E.1.1.1Medical condition in easily understood language
    Seasonal Flu due to Influenza A virus.
    La grippe saisonnière par infection au virus Influenza A.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10022002
    E.1.2Term Influenza A virus infection
    E.1.2System Organ Class 100000015765
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to assess the efficacy of the two new
    antiviral drugs (etilefrine and diltiazem), compared to placebo, to
    increase the rate of alive patient with influenza A virus
    disappearance at 7 days in patients with influenza A virus
    infection treated by oseltamivir.
    L’objectif principal est de déterminer la capacité de deux
    molecules repositionnées comme anti-viraux (etilefrine et
    diltiazem), vs placebo, à augmenter le taux de patients
    survivants avec une disparition du virus influenza A à 7 jours,
    chez des patients infectés par ce virus et traités par oseltamivir.
    E.2.2Secondary objectives of the trial
    Secondary objectives are :
    1) to determine the impact of the two new antiviral drugs,
    compared to placebo, on :
    - Delay needed for the negativation of influenza A detection.
    - Overall mortality at day 28
    - Length of mechanical ventilation.
    - Change in PaO2/FiO2 during the treatment period
    - Length of hospitalization.
    - Length of ECMO if implemented.
    2) to compare between the two new antiviral drugs the primary,
    and secondary outcomes.
    3) to evaluate the in vivo transcriptomic signature under
    treatment, for the validation of the concept of transcriptomic
    profile inversion.
    Les objectifs secondaires sont :
    1) de déterminer l’impact de ces deux nouvelles molécules
    antivirales, vs placebo, sur :
    - le délai necessaire à la négativation de la détection du virus
    Influenza A.
    - La mortalité globale à J28.
    - La durée de ventilation mécanique.
    - La variation du rapport PaO2/FiO2 durant la durée de
    traitement.
    - La durée d’hospitalisation.
    - La durée d’ECMO si il a été nécessaire d’en implanter une.
    2) de comparer entre ces deux nouvelles molécules antivirales
    les objectifs principal et secondaire.
    3) d’évaluer la signature transcriptomique in vivo sous
    traitement, pour valider le concept d’inversion du profil
    transcriptomique.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients hospitalized in intensive care units, older than 18
    years,
    - For a severe flu confirmed by positive PCR on nasopharyngeal
    swab
    - Whose evolution is less than 96 hours,
    - The severity of the flu is assessed by a respiratory failure
    defined by the necessity to resort to mechanical ventilation,
    invasive or not, or to deliver oxygen with a PaO2/FiO2<200
    mmHg.
    The inclusion is conditioned to the detection of Influenza A
    viruses by rapid detection kit on nasopharyngeal swab.
    - Written informed consent from patients or their relatives.
    - Patients hospitalisés en réanimaiton, âgés de plus de 18 ans,
    - Pour une grippe grave confirmée par une PCR positive sur un
    écouvillon nasopharyngé
    - Evoluant depuis moins de 96 heures,
    - La gravité de la grippe est déterminée par la presence d’une
    détresse respiratoire définie par la nécessité de recourir à la
    ventilation mécanique, invasive ou non invasive, pour délivrer de
    l’oxygène, avec un rapport PaO2/FiO2<200 mmHg.
    L’inclusion est conditionnée par la détection du virus Influenza A
    par un test de diagnostic rapide sur écouvillon nasopharyngé.
    - Consentement éclairé écrit donné par le patient ou l’un de ses
    représentants.
    E.4Principal exclusion criteria
    - No consent.
    - Hypersensibility to Oseltamivir.
    - Negative rapid detection kit on nasopharyngeal swab.
    - Symptoms for more than 96 hours.
    - Moribund patients at admission.
    - Contraindication to the molecules evaluated.
    - Sinusal dysfonction without device.
    - Auriculo-ventricular heart block without device.
    - Cardiogenic pulmonary oedema.
    - Bradycardia<40/min.
    - Not treated coronary insufficiency.
    - Ventricular arythmia.
    - Hyperthryroidism.
    - Non controlled hypertension.
    - Obstructive cardiomyopathy.
    - Heart valve stenosis.
    - Pheochromocytoma.
    -Concomitant use of beta-blockers, antiarythmic drugs,
    especially amiodarone.
    - Pregnant/nursing woman
    - No social insurance cover
    -Patient under a regim of juridic protection
    - Absence de consentement.
    - Hypersensibilité à l'Oseltamivir.
    - Test de detection rapide sur écouvillon nasopharyngé.
    - Symptômes depuis plus de 96 heures.
    - Patient moribond à l’admission.
    - Contre-indication aux molécules évaluaées.
    - Dysfonction sinusale non appareillée.
    - Bloc auriculo-ventriculaire non appareillé.
    - Oedème pulmonaire cardiogénique.
    - Bradycardie<40/min.
    - Insuffisance coronarienne non traitée.
    - Arythmie ventricuaire.
    - Hyperthryroidie.
    - Hypertension non contrôlée.
    - Cardiomyopathie obstructive.
    - Rétrécissement valvulaire.
    - Phéochromocytome.
    - Utilisation de beta-bloquants, medicaments antiarythmiques,
    notamment l’amiodarone.
    - Femmes enceinte ou allaitante.
    - Absence de couverture sociale.
    - Patient sous régime de protection juridique.
    E.5 End points
    E.5.1Primary end point(s)
    percentage of alive patients without detectionof influenza A virus by RT-PCR in nasopharyngeal swabs.
    pourcentage de patients survivants sans détection du virus Influenza A par RT-PCR sur écouvillon nasopharingé.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days after the beginning of the treatment.
    7 jours après le début du traitement.
    E.5.2Secondary end point(s)
    - Delay needed for the negativation of influenza A
    detection
    - Overall mortality at day 28
    - Length of mechanical ventilation.
    - Change in PaO2/FiO2 during the treatment period
    - Length of hospitalization.
    - Length of ECMO if implemented.
    - Evolution of transcriptomic profile
    Délai necessaire à la négativation de la détection
    d’Influenza A .
    - Mortalité globale à J 28.
    - Durée de ventilation mécanique.
    - Variation du rapport PaO2/FiO2 pendant le traitement.
    - Durée d’hospitalisation.
    - Durée d’ECMO si implantée.
    - Evolution du profil transcriptomique.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days.
    28 jours.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 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 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
    Last analysis of samples from the last patient enroled.
    Dernière analyse des échantillons du dernier patient 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 months
    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: 264
    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 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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    This study will be carried out in Intensive Care Units where it is expected that some patients will not have physical capabilities to give a writed consent.
    Cette étude se réalisera dans des services de réanimation où il est attendu que certains patients ne seront pas en capacité physique de donner leur consentement écrit.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state264
    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 Decision2017-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-28
    P. End of Trial
    P.End of Trial StatusOngoing
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