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    Summary
    EudraCT Number:2018-000654-22
    Sponsor's Protocol Code Number:6998
    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:2018-06-04
    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 number2018-000654-22
    A.3Full title of the trial
    A Prospective, Randomized Multicenter, Double Blind Clinical Trial Comparing
    Inhaled Dornase Alfa and Its Placebo to Reduce the Incidence of Moderate to
    Severe ARDS in Ventilated Trauma Patients in the Intensive Care Unit
    EVALUATION PROSPECTIVE RANDOMISEE EN DOUBLE AVEUGLE DE LA DORNASE ALFA, ADMINISTREE EN AEROSOLS, POUR REDUIRE L’INCIDENCE DU SYNDROME DE DETRESSE RESPIRATOIRE AIGUE MODERE ET SEVERE CHEZ LES PATIENTS TRAUMATISES GRAVES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma
    DORNASE ALFA, ADMINISTREE EN AEROSOLS, POUR REDUIRE L’INCIDENCE DU SYNDROME DE DETRESSE RESPIRATOIRE CHEZ LES PATIENTS TRAUMATISES GRAVES
    A.3.2Name or abbreviated title of the trial where available
    TRAUMADORNASE
    TRAUMADORNASE
    A.4.1Sponsor's protocol code number6998
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03368092
    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 SponsorHôpitaux Universitaires de Strasbourg
    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 supportLes Hôpitaux universitaires de Strasbourg
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpitaux Universitaires de Strasbourg
    B.5.2Functional name of contact pointDimitri Sanchez
    B.5.3 Address:
    B.5.3.1Street Address1, place de l’Hôpital,
    B.5.3.2Town/ city Strasbourg
    B.5.3.3Post code 67091
    B.5.3.4CountryFrance
    B.5.4Telephone number0033388115266
    B.5.5Fax number0033388115494
    B.5.6E-maildrci@chru-strasbourg.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 PULMOZYME
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE
    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 Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 injection
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple Trauma
    Traumatisme grave [Injury Severity Score > 15]
    E.1.1.1Medical condition in easily understood language
    Multiple Trauma
    Traumatisme grave
    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 the efficacy of early intratracheal administration of dornase alfa in reducing the incidence of moderate and severe acute respiratory distress syndrome (PaO2/FiO2 ratio < 200) during the first 7 days post-traumatic in patients with severe trauma (ISS>15) and hospitalized in intensive care.
    Démontrer l’efficacité de l’administration intratrachéale précoce de dornase alfa pour réduire l’incidence du syndrome de détresse respiratoire aigu modéré et sévère (rapport PaO2/FiO2 < 200) au cours des 7 premiers jours post-traumatiques chez les patients victimes de traumatismes graves (ISS>15) et hospitalisés en réanimation.
    E.2.2Secondary objectives of the trial
    Demonstrate the efficacy of early intratracheal administration of dornase alfa to reduce:
    the incidence of ventilation acquired pneumonia
    the impact of multi organ failure
    The incidence of minimal respiratory distress syndromes (200 < PaO2/FiO2 ≤ 300)
    the duration of mechanical ventilation (hours)
    the length of intensive care unit stay (hours)
    the length of hospital stay
    the mortality on D30
    Démontrer l’efficacité de l’administration intratrachéale précoce de dornase alfa pour réduire :
    • l’incidence des pneumopathies acquises sous ventilation mécanique
    • l’incidence de la défaillance multiviscérale
    o L’incidence des syndromes de détresse respiratoire minime (200 < PaO2/FiO2 ≤ 300)
    • la durée de ventilation mécanique post-traumatique
    • la durée de séjour en réanimation
    • la durée de séjour à l’hôpital
    • la mortalité à J30
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult (>18) patient of either sex affiliated to the National Health Service
    • Severe trauma patient (either blunt or penetrating), Injury Severity
    Score > 15
    • Under mechanical ventilation for an expected duration > 48h
    • Admitted in the ICU for less than 6 hours (or less than 18 hours after arrival at the hospital[de-shocking] in the case of prior surgery or embolization)
    • Signed informed consent from the patient’s relative
    • Patient equipped with an indwelling arterial catheter
    - Patient majeur
    - Sujet affilié à un régime de protection sociale d’assurance maladie
    - Personne de confiance ayant été informée des résultats de la visite médicale préalable
    - Patient victime d’un traumatisme grave [Injury Severity Score > 15]
    - Patient admis en réanimation depuis moins de 6h (ou moins de 18h après l’arrivée à l’hôpital [déchocage] en cas d’interventions chirurgicales ou embolisation préalables)
    - Patient intubé dont la durée prévisible de ventilation mécanique est > 48h
    - Porteur d’un cathéter artériel
    E.4Principal exclusion criteria
    • Pregnancy or breast feeding
    • Opposition from the patient or his/her relatives
    • Protected major (Guardianship)
    • Contraindication to the use of dornase alfa
    • Known intolerance to dornase alfa
    • Ventilation by high frequency oscillations
    - Opposition du patient ou de la personne de confiance
    - Patiente enceinte (test de grossesse sanguin positif)
    - Patient sous mesure de tutelle ou sauvegarde de justice
    - Hypersensibilité connue à la dornase alfa ou à l’un des excipients
    - Traitement (en cours ou antérieur) par dornase alfa
    - Ventilation par oscillations à haute fréquence
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of moderate to severe ARDS (PaO2/FiO2 < 200, according to the Berlin definition in severe trauma patients (Injury Severity Score > 15).
    Incidence du syndrome de détresse respiratoire aigue (SDRA) modéré et sévère selon la classification de Berlin (rapport PaO2/FiO2 < 200) au cours des 7 premiers jours post-traumatiques chez les patients victimes de traumatismes graves (ISS>15) et hospitalisés en réanimation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7
    A 7 jours
    E.5.2Secondary end point(s)
    1- Incidence of VAP (ATS and CDC definitions) according to both the ATS and CDC definitions.
    2- Incidence of multi-organ failure
    3- Duration of mechanical ventilation [hours]
    4- Length of ICU stay [hours]
    5- Length of stay in the hospital
    6- Mortality on day 30
    7-- Incidence of minimal ARDS with a PaO2/FiO2 ratio between 200 and 300
    1- Incidence des pneumopathies acquises sous ventilation mécanique [%] selon les définitions de
    l’American Thoracic Society (ATS et du Center for Disease Control and Prevention au cours des 7
    premiers jours post-traumatiques.
    2- Incidence de la défaillance multiviscérale [%] (selon le SOFA score au cours des 7 premiers jours
    post-traumatiques.
    3-Durée de ventilation mécanique post-traumatique [en heures] entre l’intubation et la première
    extubation réussie (définie par l’absence de recours à la ventilation invasive pendant les 48h qui
    suivent l’extubation)
    4- La durée de séjour en réanimation [en heures]
    5- La durée de séjour à l’hôpital [en jours]
    6- La mortalité à J30
    7-L’ncidence du syndrome de détresse respiratoire minime avec un rapport PaO2/FiO2 compris entre 200 et 300 [200 < PaO2/FiO2 ≤ 300]
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- day 7
    2- day 7
    3- day 7
    4- day 7
    5- day 7
    6. day 30
    7- day 7
    1- A 7 jours
    2- A 7 jours
    3- A 7 jours
    4- A 7 jours
    5- A 7 jours
    6. A 30 jours
    7- A 7 jours
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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 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 concerned7
    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 No
    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 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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state500
    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 Decision2018-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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