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    Summary
    EudraCT Number:2016-004835-19
    Sponsor's Protocol Code Number:38RC16.015
    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:2017-09-12
    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 number2016-004835-19
    A.3Full title of the trial
    Dexamethasone in Herpes Simplex Virus Encephalitis
    Open label Randomized Controlled Trial with an Observer-blinded evaluation at 6 months
    Etude multicentrique, randomisée, contrôlée, en ouvert avec évaluation en aveugle à 6 mois, visant à évaluer l’intérêt de dexaméthasone en traitement complémentaire des encéphalites à Herpès Simplex Virus.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dexamethasone in Herpes Simplex Virus Encephalitis Trial
    Etude visant à évaluer l’intérêt de dexaméthasone en traitement complémentaire des encéphalites à Herpès Simplex Virus
    A.3.2Name or abbreviated title of the trial where available
    DexEnceph
    A.4.1Sponsor's protocol code number38RC16.015
    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 SponsorUniversity Hospital Grenoble
    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
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Grenoble
    B.5.2Functional name of contact pointPr Jean-Paul STAHL
    B.5.3 Address:
    B.5.3.1Street AddressService de médecine infectieuse
    B.5.3.2Town/ cityGrenoble
    B.5.3.3Post code38043
    B.5.3.4CountryFrance
    B.5.4Telephone number+330476766813
    B.5.5Fax number+330476765906
    B.5.6E-mailjpstahl@chu-grenoble.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 dexamethasone Mylan
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN SAS
    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 Solution for injection
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HSV encephalitis
    encéphalites à HSV
    E.1.1.1Medical condition in easily understood language
    herpes virus encephalitis
    encéphalites à virus herpétique
    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 10014590
    E.1.2Term Encephalitis herpes
    E.1.2System Organ Class 100000013665
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Estimate the interest of corticoids for the improvement of the neuropsychological forecast in 6 and 18 months
    Evaluer l’intérêt des corticostéroïdes pour l’amélioration du pronostic neuropsychologique à 6 et 18 mois chez des patients traités pour encéphalites à HSV
    E.2.2Secondary objectives of the trial
    • Neuropsychological and Cognitive outcome measures [at 30 days/discharge, 6 and 18 months]
    • Clinical Outcome
    • Functional Outcomes [at 30 days/discharge, 6 months and 18 months]
    • Imaging Outcomes [Baseline, 2 weeks, 6 months and 18 months]
    • Biomarker outcomes [Baseline, 4 days, 2 weeks, 6 months months]
    • Safety Outcomes [2 weeks]
    • Health Status and Quality of Life [6 months and 18 months]
    • Evolution neuropsychologique et cognitive à 30 jours, 6 et 18 mois
    • Evolution clinique
    • Evolution fonctionnelle à 30 jours, 6 et 18 mois
    • Imagerie à l’inclusion, 2 semaines, 6 et 18 mois
    • Evaluation des biomarqueurs à l’inclusion, 4 jours 2 semaines, 6 et 18 mois
    • Evaluation de la sécurité à 2 semaines
    • Evaluation de la qualité de vie à 6 et 18 mois
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Suspected encephalitis criteria:
    Acute or subacute (up to 4 weeks) alteration in consciousness, cognition, personality or behaviour* persisting for > 24 hours.
    2. Laboratory confirmed HSV by positive PCR on CSF sample.
    3. Receiving intravenous aciclovir dosed at 10mg/kg TDS or at a reduced dose in renal impairment
    4. Age ≥ 18 years
    5. Written informed consent has been given by the patient or their legal representative
    1. Critères d’encéphalite:
    Altération aiguë ou subaiguë (jusqu’à 4 semaines) de la conscience, de la connaissance, de la personnalité ou trouble du comportement persistant plus de 24 heures.
    2. Encéphalite à HSV confirmée par une PCR positive dans le LCS.
    3. Traité par aciclovir intraveineux, 10mg/kg X3 par jour ou à une posologie adaptée en cas d’insuffisance rénale
    4. Age ≥ 18 ans
    5. Consentement éclairé signé par le patient ou son représentant légal
    E.4Principal exclusion criteria
    1. Currently receiving oral or injectable corticosteroid therapy; including treatment with oral or injectable corticosteroids in the last 30 days.
    2. History of hypersensitivity to corticosteroids
    3. Immunosuppression secondary to:
    - Known HIV infection & CD4 count under 200cell/mm3
    - Biologic therapy or other immunosuppressive agents [azathioprine, methotrexate, ciclosporin]
    - Solid organ transplant on immunosuppression
    - Bone marrow transplant
    - Currently undergoing a course of chemotherapy or radiotherapy
    - Known immunodeficiency syndrome [other than HIV]
    - Known haematological malignancy
    4. Pre-existing indwelling ventricular devices
    5. Peptic ulcer disease in the last 6 months: defined as a peptic ulcer seen at previous endoscopy or an upper gastrointestinal bleed causing ≥ 2 unit haemoglobin drop
    6. Currently on an antiretroviral regime containing rilpivirine
    7. Subject under administrative or judicial control, person who are protected under the act.
    8. Pregnant women, breastfeeding and parturient
    1. Traitement en cours par corticoïdes par voie orale ou injectable ou administré dans les 30 jours précédents
    2. Antécédents d’hypersensibilité aux corticoïdes
    3. Immunosuppression secondaire à:
    a. Infection connue par le VIH et taux de CD4 < 200 cellules/mm3
    b. Biothérapie ou autres traitements immunosuppresseurs [azathioprine, methotrexate, ciclosporine]
    c. Transplantation d’organe solide ou immunosuppression
    d. Greffe de moelle
    e. Chimiothérapie ou radiothérapie en cours
    f. Syndrome d’immunodépression [autre que VIH]
    g. Hémopathie connue
    4. Dérivation ventriculaire pré-éxistante
    5. Ulcère peptique gastrique dans les 6 mois précédents: objectivé au cours d’une endoscopie précédente ou une hémorragie digestive haute responsable d’une perte de 2 points d’hémoglobine
    6. Traitement antirétroviral contenant de la rilpivirine, en cours
    7. Patients protégés par les articles L1121-6 et L1121-7 du code de la santé publique
    E.5 End points
    E.5.1Primary end point(s)
    Verbal memory score, as determined by the Wechsler Memory Scale (WMS-IV) Auditory Memory Index
    Wechsler Memory Scale (WMS-IV) Auditory Memory Index
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    E.5.2Secondary end point(s)
    Neuropsychological outcome measures [6 months and 18 months]
    - Visual, immediate and delayed memory (WMS-IV), Processing speed and working memory(WAIS-IV), Language (NAB) & Higher executive function (Trail Making Tests Past A and B)
    - Anxiety and Depression (BDI & BAI)
    - Premorbid cognitive ability (TOPF)
    - Subjective cognitive complaints (Perceived Deficits Questionnaire)

    Cognitive Outcome Measures [at 30 days/discharge, 6 and 18 months]
    - Addenbrooke’s Cognitive Assessment revised (ACE-III)

    Clinical Outcome
    - Incidence of epilepsy
    - Time to hospital discharge
    - Requirement of HDU/ITU admission
    - Time to cessation of ventilator support [if any]
    - Time to recovery of GCS
    - Survival

    Functional Outcomes [at 30 days/discharge, 6 months and 18 months]
    - Modified Rankin Score, Barthel Index, Liverpool Outcome Score and Glasgow Outcome Score

    Imaging Outcomes [Baseline, 2 weeks, 6 months and 18 months]
    - Temporal lobe volume (as % of intra-cranial volume).
    - Whole brain volume (as % of intra-cranial volume).
    - Volume of affected region as seen on FLAIR image (as % of intra-cranial volume).
    - Volume of affected region as seen on diffusion-weighted image (as % of intra-cranial volume).

    Biomarker outcomes [Baseline, 4 days, 2 weeks, 6 months months]
    - Transcriptomic and proteomic profiling on blood at baseline, 4 days, 2 weeks and 6 months & CSF at baseline and 2 weeks
    - Anti NMDA receptor antibody testing at 4 days and 6 months

    Safety Outcomes [2 weeks]
    - Proportion of patients with detectable HSV in CSF

    Health Status and Quality of Life [at 6 and 18 months]
    - Measured by the EuroQOL-5D-5L and SF-36

    Evaluation Neuropsychologique et cognitive à 30 jours, 6 et 18 mois
    1. Wechsler Memory Scale version IV (WMS-IV);
    2. Wechsler Adult Intelligence Scale version IV (WAIS-IV);
    3. Language Module in the Neuropsychology Assessment Battery (NAB);
    4. Trail Making Test Parts A and B;
    5. Test of Premorbid Function (TOPF);
    6. Tests auto-administrés: Beck Depression Inventory et Beck Anxiety Inventory;
    7. Questionnaire sur la perception d’un déficit
    8. Addenbrooke’s Cognitive Assessment (ACE-III)

    Evaluation fonctionnelle à 30 jours, 6 et 18 mois
    Modified Rankin Score, Barthel Index, Liverpool Outcome Score and Glasgow Outcome Score

    Evaluation Clinique
    - Incidence d’épilepsie
    - Durée d’hospitalisation
    - Requirement of HDU/ITU admission
    - durée de la ventilation mécanique (si nécessaire)
    - délais de retour à un score Glasgow normal
    - survie

    Imagerie à l’inclusion, 2 semaines, 6 et 18 mois
    - Mesure du volume du lobe temporal
    - Mesure du volume cérébral global
    - Mesure du Volume de la région atteinte

    Evolution des biomarqueurs
    - profil transcriptomique et protéomique sur le LCR à l’inclusion, et J+ 2 semaines; sur le sang à l’inclusion, J+4 jours, 2 semaines et 6 mois
    - Anticorps Anti récepteur-NMDA évalués à J+4 et J+ 6 mois

    Evaluation de la sécurité
    - Proportion de patients pour laquelle un HSV positif est détecté au bout de 2 semaines dans le LCR

    Evaluation de la qualité de vie à 6 et 18 mois
    Mesurée via les questionnaires EuroQOL-5D-5L et SF-36
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline,
    J+4 days
    2 weeks
    30 days/discharge
    6 months
    18 months
    a l'inclusion,
    J+4 jours
    2 semaines
    30 jours ou sortie de l’hôpital
    6 mois
    18 mois
    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 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 Yes
    E.8.1.7.1Other trial design description
    L'évaluation de l'objectif principal sera faite par un évaluateur en aveugle
    The primary outcome will be observer blinded.
    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
    pas de comparateur, il n'y a pas de dexamethasone dans le 2nd groupe
    no comparator, the second arm doesn't received dexamethasone
    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 concerned9
    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
    la fin de l'étude correspond à la dernière visite du dernier patient inclus.
    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 months6
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 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.3.3.6.1Details of subjects incapable of giving consent
    Patients eligible with suspected encephalitis may not have capacity to provide valid informed consent at this time. A medically qualified clinician will assess capacity and confirm the patient lacks capacity and write this in the medical notes.
    possibilité d’inclure des patients dans l’urgence en faisant consentir leurs proches ou via une déclaration investigateur. Un consentement de poursuite du patient sera recherché dès qu’il sera jugé apte à consentir.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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
    pratique courante
    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 Decision2017-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-10
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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