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    Summary
    EudraCT Number:2020-001813-18
    Sponsor's Protocol Code Number:AOI_2019_JABAUDON
    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:2020-06-03
    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 number2020-001813-18
    A.3Full title of the trial
    Randomized Clinical Trial of Inhaled Sedation with Sevoflurane in Critically Ill Patients at Risk of Developing the Acute Respiratory Distress Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized Clinical Trial of Inhaled Sedation with Sevoflurane in Critically Ill Patients at Risk of Developing the Acute Respiratory Distress Syndrome
    A.3.2Name or abbreviated title of the trial where available
    IPA Study
    A.4.1Sponsor's protocol code numberAOI_2019_JABAUDON
    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 de CLERMONT-FERRAND
    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 supportCHU Clermont-Ferrand (AOI-2019)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU CLERMONT-FERRAND
    B.5.2Functional name of contact pointInvestigator Coordonator
    B.5.3 Address:
    B.5.3.1Street Address1 place Lucie et Raymond Aubrac
    B.5.3.2Town/ cityCLERMONT-FERRAND
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number+330473750501
    B.5.5Fax number+330473750500
    B.5.6E-mailmjabaudon@chu-clermontferrand.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 SEVOFLURANE
    D.2.1.1.2Name of the Marketing Authorisation holderAbbvie
    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 nameSEVOFLURANE
    D.3.4Pharmaceutical form Inhalation vapour, liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSEVOFLURANE
    D.3.9.1CAS number 28523-86-6
    D.3.9.3Other descriptive nameSEVOFLURANE
    D.3.9.4EV Substance CodeSUB10506MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.2 to 1.2
    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
    Patients in ICU with risks of Acute Respiratory Distress Syndrome
    E.1.1.1Medical condition in easily understood language
    Patients in ICU with risks of Acute Respiratory Distress Syndrome
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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 assess the efficacy of inhaled sevoflurane, compared to current intravenous sedation practice, for improving PaO2/FiO2 in ICU patients at high risk for ARDS.
    E.2.2Secondary objectives of the trial
    - Progression to ARDS, as defined by the Berlin criteria1 .
    - Safety (clinical adverse events) of the two sedation strategies.
    - Effects on the rate of pneumonia.
    - Effects on respiratory mechanics.
    - Effects on gas exchange and physiologic measures.
    - Effects on ICU-acquired delirium.
    - Effects on ICU-acquired weakness.
    - Effects on hemodynamic measures and renal function (KDIGO criteria for acute kidney injury24).
    - Effects on organ dysfunction.
    - Effects on the duration of mechanical ventilation.
    - Effects on 28-day mortality.
    - Effects on the number of days off the ventilator at 28 days (ventilator-free days to day 28, VFD28), taking into account death as a competing event.
    - Biological collection of plasma, alveolar edema fluid, and urine samples for future mechanistic and endotyping studies of the biological effects of sevoflurane.
    - Presence of subphenotypes among patients at risk of developing ARDS;
    - Hhealthcare-related costs during ICU stay and hospital stay.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Admitted to participating ICUs with at least one known risk factor for ARDS and a LIPS equals to, or greater than, 4 (Appendix G)105
    3. Patient under invasive mechanical ventilation
    4. With expected duration of sedation superior or equal to 4 hours
    5. Affiliation to the French Sécurité Sociale
    E.4Principal exclusion criteria
    - Patient under a tutelage measure
    - Known pregnancy
    - Presence of ARDS prior to randomization
    - Endotracheal ventilation for greater than 24 hours prior to randomization
    - Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing
    - Tidal volume of 6 mL/kg predicted body weight (PBW) below 200 mL (i.e. height inferior to 134cm for a man and 139cm for a woman)
    - Moribund patient, i.e. not expected to survive 24 hours despite intensive care
    - Previous hypersensitivity or anaphylactic reaction to sevoflurane
    - Medical history of malignant hyperthermia
    - Long QT syndrome at risk of arrhythmic events
    - Medical history of liver disease attributed to previous exposure to a halogenated agent (including sevoflurane)
    - Suspected or proven intracranial hypertension
    - Enrollment in another interventional trial with direct impact on oxygenation
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is longitudinal evolution in the PaO2/FiO2 ratio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 5 after admission in ICU.
    E.5.2Secondary end point(s)
    - Progression to ARDS will be assessed according to the Berlin criteria, including chest radiographs.
    - Rate of pneumonia
    - Ventilator-free days
    - Organ failure-free days
    - Mortality
    - Length of ICU-stay
    - Physiological measures
    - ICU-acquired weakness
    - ICU-acquired delirium
    - Health economic analysis
    - Biomarker measurements
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 28
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned2
    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
    A data monitoring and safety committee will be convened to discuss the continuation of this study in case of a between-group difference in severe adverse events (SAEs) or suspected unexpected severe adverse events (SUSAEs).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months28
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    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)
    Normal treatment of that condition
    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 Decision2020-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-02
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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