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    Summary
    EudraCT Number:2016-002146-23
    Sponsor's Protocol Code Number:ASN100-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-12-09
    Trial results View 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 number2016-002146-23
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Single Dose of ASN100 for the Prevention of Staphylococcus aureus Pneumonia in Heavily Colonized, Mechanically Ventilated Subjects
    Estudio en fase II, randomizado, doble ciego, y controlado con placebo para determinar la seguridad y la eficacia de una dosis única de ASN100 en la prevención de la neumonía por Staphylococcus aureus en sujetos con ventilación mecánica muy colonizados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of ASN100 in Ventilated Subjects
    Estudio de ASN100 en sujetos con ventilación
    A.4.1Sponsor's protocol code numberASN100-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02940626
    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 SponsorArsanis, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportArsanis, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace Czech Republic s.r.o
    B.5.2Functional name of contact pointRegulatory Submissions
    B.5.3 Address:
    B.5.3.1Street AddressPrague Office Park II, K Hajum 2606/2b
    B.5.3.2Town/ cityPrague
    B.5.3.3Post code15000
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+4202515514664169
    B.5.5Fax number+420251510801
    B.5.6E-mailregsubmissions@medpace.com
    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 No
    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 nameASN-1
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.3Other descriptive nameASN-1
    D.3.9.4EV Substance CodeSUB178400
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.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 No
    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 nameASN-2
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.3Other descriptive nameASN-2
    D.3.9.4EV Substance CodeSUB178401
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of Staphylococcus aureus Pneumonia in Heavily Colonized, Mechanically Ventilated Subjects
    Prevención de la neumonía por Staphylococcus aureus en sujetos con ventilación mecánica muy colonizados
    E.1.1.1Medical condition in easily understood language
    Pneumonia in Mechanically Ventilated Subjects
    Neumonía en sujetos con ventilación mecánica
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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 evaluate the safety, tolerability, and efficacy of a single dose of ASN100 (administered as ASN-1 and ASN-2 components) versus placebo for the prevention of S. aureus pneumonia in mechanically ventilated subjects who are heavily colonized with S. aureus.
    •Evaluar la seguridad, la tolerabilidad y la eficacia de una dosis única de ASN100 (administrada en forma de los componentes ASN-1 y ASN-2) en comparación con placebo para la prevención de la neumonía por S. aureus en pacientes con ventilación mecánica que están muy colonizados por S. aureus.
    E.2.2Secondary objectives of the trial
    •To compare the duration of mechanical ventilation post-treatment in subjects treated with ASN100 versus placebo;
    •To compare the length of stay in the intensive care unit (ICU) post-treatment for subjects treated with ASN100 versus placebo;
    •To determine the serum pharmacokinetics (PK) (i.e., maximum serum concentration [Cmax], time to maximum serum concentration [Tmax], area under the serum concentration-time curve [AUC], and terminal elimination half-life [t1/2]) of ASN-1 and ASN-2 in mechanically ventilated subjects heavily colonized with S. aureus; and
    •To compare 28-day all-cause mortality in subjects treated with ASN100 versus placebo.
    •Comparar la duración de la ventilación mecánica posterior al tratamiento en sujetos tratados con ASN100 en comparación con el placebo.
    •Comparar la duración de la estancia en la unidad de cuidados intensivos (UCI) después del tratamiento en los sujetos tratados con ASN100 en comparación con el placebo.
    •Determinar la farmacocinética (FC) sérica (es decir, la concentración máxima en suero [Cmáx], el tiempo hasta la concentración máxima en suero [Tmáx], el área bajo la curva [ABC] concentración-tiempo en suero, y la semivida de eliminación terminal [t1/2]) de ASN-1 y ASN-2 en sujetos con ventilación mecánica muy colonizados por S. aureus; y
    •Comparar la mortalidad por cualquier causa a los 28 días en sujetos tratados con ASN100 en comparación con el placebo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Bronchoalveolar lavage (BAL) fluid pharmacokinetic sub-study
    Approximately 20 subjects will participate in this sub-study and will have BAL fluid collected 48 hours (±36 hours) post-dose (on Day 2 or Day 3, depending on time of study drug administration) to determine ASN-1 and ASN-2 levels and and calculate a blood to epithelial lining fluid (ELF) ratio.
    The version date and number are the same as the ASN100-201 study
    Subestudio de farmacocinética de lavado broncoalveolar (LBA).
    Aproximadamente 20 sujetos participarán en este subestudio y se les recogerá líquido de LBA 48 horas (±36 horas) después de la dosis (el día 2 o día 3, dependiendo del momento de la administración del fármaco del estudio) para determinar los niveles de ASN-1 y ASN-2 y la relación entre sangre y LRE.
    La fecha y número de versión son las mismas que para el estudio ASN100-201.
    E.3Principal inclusion criteria
    1.Subject or legally authorized representative has provided written informed consent;
    2.Subject is 18 years of age or older at the time of enrollment;
    3.Subject is currently hospitalized and is mechanically ventilated endotracheally and, in the Investigator’s opinion, will require ongoing ventilator support for at least 48 hours;
    NOTE: Subjects with a chronic tracheostomy are not eligible.
    4.Female subjects must not be pregnant or lactating. Female subjects of childbearing potential must have a documented negative pregnancy test at Screening. Female subjects may be enrolled on the basis of a negative urine pregnancy test, pending the result of a negative serum pregnancy test prior to randomization; and
    5.Female subjects of childbearing potential and non-surgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 165 days post dose. Approved forms of contraception include hormonal intrauterine devices (IUD), hormonal contraceptives (oral birth control pill, depot, patch or injectable) together with supplementary double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
    NOTE: The following categories define women who are NOT considered to be of childbearing potential:
    •Premenopausal female with 1 of the following:
    o Documented hysterectomy,
    o Documented bilateral salpingectomy, or
    o Documented bilateral oophorectomy, or
    •Postmenopausal female, defined as having amenorrhea for at least 12 months without an alternative medical cause.
    1.El sujeto o su representante legal ha otorgado su consentimiento informado por escrito.
    2.El sujeto tiene 18 años de edad o mas en el momento de la inclusión.
    3.El sujeto está hospitalizado en la actualidad y lleva ventilación mecánica endotraqueal y, en opinión del investigador, necesitará asistencia respiratoria continua durante al menos 48 horas.
    NOTA: los sujetos con traqueotomía no son aptos.
    4.Las mujeres no deben estar embarazadas ni en periodo de lactancia. Las mujeres en edad fértil deben aportar una prueba de embarazo negativa documentada en la selección. Las mujeres pueden incluirse en función de una prueba de embarazo en orina negativa, a la espera del resultado de una prueba de embarazo en suero negativa antes de la randomización; y
    5.Las mujeres en edad fértil y los varones no esterilizados quirúrgicamente que sean sexualmente activos deben estar de acuerdo en usar una forma de anticoncepción de alta
    eficacia desde el momento del consentimiento hasta 165 días después de la dosis. Los métodos anticonceptivos aprobados incluyen dispositivos intrauterninos (DIU)
    hormonales, anticonceptivos hormonales (píldora anticonceptiva oral, de liberación prolongada, parches o inyectables) junto con métodos de barrera doble complementarios como preservativos o diafragmas con gel o espuma espermicida.
    NOTA: las siguientes categorías definen a las mujeres que NO se consideran en edad fértil:
    •Mujer premenopáusica con 1 de los elementos que siguen:
    o Histerectomía documentada,
    o Salpingectomía bilateral documentada, u
    o Ovariectomía bilateral documentada, o
    •Mujer posmenopáusica, definida como tener amenorrea durante al menos 12 meses sin una causa médica alternativa.
    E.4Principal exclusion criteria
    1.Subject has received intravenous (IV) immunoglobulin therapy within 4 months prior to Screening;
    2.Subject has a chest X-ray or thoracic computed tomography (CT) scan showing new or progressive infiltrates consistent with the diagnosis of pneumonia;
    3.Subject demonstrates both of the following:
    a.Need for acute changes in ventilator support to enhance oxygenation or to the amount of positive end-expiratory pressure; and
    NOTE: Changes made in ventilator support due to day to day maintenance other than those changes made to improve oxygenation will not exclude a subject from participation in the study.
    b.New onset of purulent suctioned respiratory secretions;
    4.Subject has a condition at baseline (e.g., traumatic chest injury with paradoxical breathing OR congestive cardiac failure with bilateral infiltrates) which precludes the radiologic diagnosis of HABP/VABP;
    5.Subject has known pulmonary heavy colonization or infection with a Gram-negative organism;
    NOTE: Randomization should not be delayed while waiting for Gram-negative results if heavy colonization with S. aureus has been confirmed.
    6.Subject has been diagnosed with neutropenia (absolute neutrophil count 500/mm3);
    7.Subject has a severe non-pulmonary source of infection which, in the Investigator’s opinion, would interfere with the conduct of the study or jeopardize the subject’s safety;
    8.Subject is currently on either continuous veno- venous hemodialysis or extracorporeal membrane oxygenation;
    9.Subject has been previously exposed to ASN100 or ASN-1 or ASN-2, individually;
    10.Subject has a known hypersensitivity to ASN100 or any of its excipients;
    11.Subject has received any investigational product within 30 days prior to the Screening Visit (or 5 half-lives of the investigational product, whichever is longer);
    12.Subject has, in the opinion of the Investigator, a high probability of death within 72 hours of randomization;
    13.Subject is, in the opinion of the Investigator, not able or willing to comply with the protocol;
    14.Any disease or condition (medical or surgical) which, in the opinion of the Investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, endocrine, autoimmune, gastrointestinal, hepatic, skeletal, or central nervous system; or other conditions that, in the opinion of the Investigator, would interfere with the absorption, distribution, metabolism or excretion of ASN100, or would place the subject at increased risk; or
    15.Subjects with (suspected) previous diagnosis of cytokine release syndrome.
    1.El sujeto ha recibido tratamiento intravenoso (i.v.) de inmunoglobulinas en los 4 meses previos a la selección.
    2.El sujeto tiene una radiografía torácica o tomografía computarizada (TAC) torácica que muestra infiltrados nuevos o progresivos congruentes con el diagnóstico de neumonía.
    3.El sujeto demuestra ambos de los factores que siguen:
    a. Necesidad de cambios agudos en el soporte respiratorio para mejorar la oxigenación o en la cantidad de presión positiva al final de la espiración; y
    NOTA: los cambios en el soporte respiratorio debidos al mantenimiento diario aparte de los cambios hechos para mejorar la oxigenación no excluirán a un sujeto de su
    participación en el estudio.
    b. Secreciones respiratorias purulentas aspiradas de nueva aparición.
    4.El sujeto tiene alguna condición al inicio (p. ej., lesión torácica traumática con respiración paradójica O insuficiencia cardiaca congestiva con infiltrados bilaterales) que impide el diagnóstico radiológico de NBAH/NBAV.
    5.El sujeto tiene amplia colonización pulmonar conocida o infección por un organismo gramnegativo;
    NOTA: la randomización no debe retrasarse mientras se esperan los resultados para los microorganismos gramnegativos si se ha confirmado la fuerte colonización por S. aureus.
    6.Al sujeto se le ha diagnosticado neutropenia (recuento absoluto de neutrófilos <500/mm3);
    7.El sujeto tiene una fuente no pulmonar de infección grave que, en opinión del investigador, interferiría con la realización de la realización del estudio o pondría en peligro la seguridad del sujeto.
    8.El sujeto está recibiendo en la actualidad hemodiálisis venovenosa continua u oxigenación por la membrana extracorporal.
    9.El sujeto ha estado expuesto previamente a ASN100 o ASN-1 o ASN-2, de forma individual.
    10.El sujeto tiene hipersensibilidad conocida a ASN100 o a alguno de sus excipientes.
    11.El sujeto ha recibido algún producto en investigación en los 30 días previos a la visita deselección (o 5 semividas del producto en investigación, lo que sea más prolongado).
    12-El sujeto tiene, en opinión del investigador, una alta probabilidad de muerte en el plazo de 72 horas desde la randomización.
    13.El sujeto, en opinión del investigador, no es capaz o no tiene la voluntad de cumplir con el protocolo.
    14.Cualquier enfermedad o trastorno (médico o quirúrgico) que, en opinión del investigador, podría comprometer el sistema hematológico, cardiovascular, pulmonar, renal, endocrino, autoinmunitario, gastrointestinal, hepático, esquelético o nervioso central; u otros trastornos que, en opinion del investigador, interferirían con la absorción, distribución, metabolismo o excreción de ASN100, o quepodrían poner al sujeto en un mayor riesgo; o
    15.Sujetos con (sospecha de) diagnóstico previo de síndrome de liberación de citocinas.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects in the Modified Intent-to-Treat (MITT) Population who develop S. aureus pneumonia up to Day 22.
    La proporción de sujetos en la población por intención de tratar modificada (IDTm) que desarrollen neumonía por S. aureus hasta el día 22.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endotracheal aspirates will be collected for culture during the screening period to determine the degree of S. aureus. Additional respiratory specimens may be collected throughout the monitoring period if clinically indicated. Subjects will be assessed daily throughout the monitoring period for clinical signs and symptoms of pneumonia.
    Se recogerán aspirados endotraqueales para su cultivo durante la fase de selección para determinar el grado de colonización por S. aureus.
    Se podrán recoger muestras respiratorias adicionales para su cultivo a lo largo del periodo de monitorización si está clínicamente indicado.
    Se valorará a los sujetos diariamente a lo largo del periodo de monitorización para detectar signos clínicos y síntomas de neumonía.
    E.5.2Secondary end point(s)
    •Duration of mechanical ventilation during the first 21 days post-randomization for subjects in the MITT, Intent-to-Treat (ITT), and Per Protocol (PP) Populations;
    •Length of ICU stay during the first 21 days post-randomization for subjects in the MITT, ITT, and PP Populations;
    •The Cmax, Tmax, AUC, and t1/2 of ASN-1 and ASN-2 in serum following a single dose of ASN100 in the PK Population; and
    •28-day all-cause mortality in the MITT Population.
    •La duración de la ventilación mecánica durante los primeros 21 días después de la randomización para los sujetos de las poblaciones IDTm, Poblción por intención de tratar(IDT) y población por protocolo (PP).
    •La duración de la estancia en la UCI durante los primeros 21 días después de la randomización para los sujetos de las poblaciones IDTm, IDT y PP.
    •La Cmáx, Tmáx, ABC, y t1/2 de ASN-1 y ASN-2 en suero tras una dosis única de ASN100 en la población FC.
    •Mortalidad por cualquier causa a los 28 días en la población IDTm.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Microbiological and clinical assessments will be done throughout the monitoring period.
    Se realizarán evaluaciones microbiológicas y clínicas durante todo el periodo de monitorización
    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 Yes
    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) 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA45
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Poland
    Portugal
    Russian Federation
    Spain
    United States
    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
    UVUP(última visita del último paciente)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 254
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects maybe ventilated and not fully conscious
    Los sujetos pueden estar ventilados y no completamente conscientes
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 275
    F.4.2.2In the whole clinical trial 354
    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)
    Patient will return to standard of care
    El paciente regresará al tratamiento 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 Decision2017-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-27
    P. End of Trial
    P.End of Trial StatusCompleted
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