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    Summary
    EudraCT Number:2018-000634-35
    Sponsor's Protocol Code Number:ALT-OXI-2018
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-02
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-000634-35
    A.3Full title of the trial
    HIGH-FLOW NASAL CANNULA THERAPY AS AN ADJUVANT IN THE TREATMENT OF SEVERE SEPSIS. A Multicenter parallel-group randomized clinical trial.
    LA OXIGENOTERAPIA DE ALTO FLUJO COMO ADYUVANTE EN EL TRATAMIENTO DE LA SEPSIS GRAVE. Ensayo clínico aleatorizado multicéntrico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OXYGEN in high pressure in treatment of severe sepsis
    Oxygeno en alta presion en tratamiento de sepsis grave
    A.3.2Name or abbreviated title of the trial where available
    OPTISEPSIS
    A.4.1Sponsor's protocol code numberALT-OXI-2018
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03334227
    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 SponsorAlthaia Xarxa Assistencial Universitària de Manresa. Fundació Privada.
    B.1.3.4CountrySpain
    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 supportInstituto de Salud Carlos III del Ministerio de Economía, Industria y Competitividad.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlthaia Xarxa Assistencial Universitària de Manresa. Fundació Privada.
    B.5.2Functional name of contact pointRafael
    B.5.3 Address:
    B.5.3.1Street AddressJoan Soler 1
    B.5.3.2Town/ cityManresa
    B.5.3.3Post code08243
    B.5.3.4CountrySpain
    B.5.4Telephone number619835178
    B.5.6E-mailrfernandezf@althaia.cat
    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.2.5The 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 nameOxygen
    D.3.2Product code Oxygen
    D.3.4Pharmaceutical form Inhalation vapour
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    Nasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.3Other descriptive nameOxigeno
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.21 to 0.50
    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 RoleComparator
    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.2.5The 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 nameOxygen
    D.3.2Product code Oxygen
    D.3.4Pharmaceutical form Inhalation vapour
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    Nasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.3Other descriptive nameoxígeno
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.21 to 0.5
    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.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 > 18 yr. with diagnostic criteria for severe sepsis, within 6 hours of admission in the Emergency Room, defined as hypotension after hemodynamic resuscitation, initial lactate > 4, or persistence of organ dysfunction (oliguria < 0.5 ml/kg/h, cyanosis, or altered consciousness).(qSOFA 1, 2 or 3)
    Pacientes mayores de 18 años, con criterios diagnósticos de sepsis grave en las primeras 6 horas del ingreso en Urgencias definidos como hipotensión tras reanimación hemodinámica, lactato inicial >4, o persistencia de disfunción orgánica (oliguria <0,5 ml/kg/hora, cianosis, livideces, alteración de la conciencia).
    E.1.1.1Medical condition in easily understood language
    Patients with diagnostic criteria for severe sepsis, within 6 hours of admission in the Emergency Room,
    Pacientes con sepsis grave que acudan a urgencias .
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    Improve in-hospital mortality from 30% basal to 20% with high-flow oxygen therapy in patients with severe sepsis, measured from the signing of the consent to hospital discharge.
    Mejorar la mortalidad hospitalaria del 30% basal hasta el 20% con oxigenoterapia de alto flujo en pacientes con sepsis grave, medida desde la firma del consentimiento hasta el alta hospitalaria.
    E.2.2Secondary objectives of the trial
    Reduce the need for mechanical ventilation, measured as days free of mechanical ventilation in the first 28 days.
    - Reduce the need for dialysis, measured as dialysis-free days in the first 28 days.
    - Reduce the need for vasoactive drugs, measured as the days free of vasoactive drugs in the first 28 days.
    - Reduce organic failures, measured by SOFA scale during the first 28 days.
    - Physiological: improve acidosis, clearance of lactate, and SvcO2 in the first 72 hours.
    - Reducir la necesidad de ventilación mecánica, medida como los días libres de ventilación mecánica en los primeros 28 días.
    - Reducir la necesidad de diálisis, medida como los días libres de diálisis en los primeros 28 días.
    - Reducir la necesidad de drogas vasoactivas, medida como los días libres de drogas vasoactivas en los primeros 28 días.
    - Reducir los fracasos orgánicos, medidos por escala SOFA durante los primeros 28 días.
    - Fisiológicos: mejorar la acidosis, el aclaramiento de lactato, y la SvcO2 en las primeras 72 horas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients > 18 years, with diagnostic criteria of severe sepsis in the first 6 hours after admission to the Emergency Room defined as hypotension after hemodynamic resuscitation, initial lactate> 4, or persistence of organic dysfunction (oliguria <0.5 ml / kg / hour, cyanosis, lividities, altered consciousness
    Pacientes mayores de 18 años, con criterios diagnósticos de sepsis grave en las primeras 6 horas del ingreso en Urgencias definidos como hipotensión tras reanimación hemodinámica, lactato inicial >4, o persistencia de disfunción orgánica (oliguria <0,5 ml/kg/hora, cianosis, livideces, alteración de la conciencia).
    E.4Principal exclusion criteria
    - Patients requiring immediate ventilatory support, both invasive and non-invasive, defined by severe hypoxemia (PaO2 / FiO2 <150), severe tachypnea (40x ') with signs of respiratory fatigue or low level of consciousness (Glasgow <8).
    - Patients with limited therapeutic effort or orders of non-CPR.
    - Patients not susceptible to treatment with OAF (facial trauma, tracheostomized, rejection of previous treatments with OAF).
    - Participation in other clinical trials that may affect survival.
    - Pregnant women.
    - Pacientes que requieran soporte ventilatorio inmediato, tanto invasivo como no invasivo, definido por hipoxemia severa (PaO2/FiO2 <150), taquipnea severa (40x’) con signos de fatiga respiratoria o bajo nivel de conciencia (Glasgow < 8).
    - Pacientes con limitación del esfuerzo terapéutico u órdenes de no RCP.
    - Pacientes no susceptibles de tratamiento con OAF (traumatismo facial, traqueostomizados, rechazo a anteriores tratamientos con OAF).
    - Participación en otros ensayos clínicos que puedan afectar a la supervivencia.
    - Mujeres embarazadas.
    E.5 End points
    E.5.1Primary end point(s)
    Mortality
    Mortalidad al alta hospitalaria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the hospitalization
    Durante la hospitalización
    E.5.2Secondary end point(s)
    In the first 28 days: need for mechanical ventilation, dialysis, vasoactive drugs, organic failure according to the SOFA scale. In the first 72 hours: improvement of acidosis, clearance of lactate and SvO2
    En los primeros 28 días: necesidad de ventilación mecánica, de diálisis, de drogas vasoactivas, fracaso orgánico según escala SOFA. En las primeras 72 horas: mejoría de la acidosis, aclaramiento del lactato y SvO2
    E.5.2.1Timepoint(s) of evaluation of this end point
    In the first 28 days
    En los primeros 28 días
    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 No
    E.6.4Safety Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned5
    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 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: 592
    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 No
    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
    592 adult patients with a diagnosis of severe sepsis in the first 6 hours of admission in the Emergency Room . Their legal representative or relative will assigned the inform consent
    Pacientes con sepsis grave. Su representante legal o su familiar firmará el consentimiento legal
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state592
    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
    Practica clinica habitual
    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 Decision2018-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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