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    Summary
    EudraCT Number:2016-004261-10
    Sponsor's Protocol Code Number:AR-105-002
    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:2017-04-07
    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 number2016-004261-10
    A.3Full title of the trial
    Placebo-controlled, double-blind, randomized study of Aerucin® as
    adjunct therapy to antibiotics in the treatment of P. aeruginosa
    pneumonia
    Estudio aleatorizado doble ciego controlado con placebo de Aerucin® como terapia adyuvante a los antibióticos en el tratamiento de la neumonía por P. aeruginosa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Placebo-controlled, double-blind, randomized study of Aerucin® as
    adjunct therapy to antibiotics in the treatment of P. aeruginosa
    pneumonia
    Estudio aleatorizado doble ciego controlado con placebo de Aerucin® como terapia adyuvante a los antibióticos en el tratamiento de la neumonía por P. aeruginosa.
    A.4.1Sponsor's protocol code numberAR-105-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03027609
    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 SponsorAridis Pharmaceuticals, 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 supportAridis Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAridis Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Group
    B.5.3 Address:
    B.5.3.1Street Address5941 Optical Court
    B.5.3.2Town/ citySan Jose
    B.5.3.3Post codeCA 95138
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1408385 1742
    B.5.5Fax number+1408960 3822
    B.5.6E-maildelamepa@aridispharma.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 nameAerucin®
    D.3.2Product code AR-105
    D.3.4Pharmaceutical form Concentrate for 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 INNINN name not assigned yet
    D.3.9.2Current sponsor codeAerucin®
    D.3.9.3Other descriptive nameAR-105, CM101, F429, aerubumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number27.5
    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) Yes
    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 placeboConcentrate for solution for infusion
    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
    P. aeruginosa pneumonia
    Neumonia P. aeruginosa
    E.1.1.1Medical condition in easily understood language
    Pneumonia caused by bacteria P. aeruginosa
    Neumonía causada por la bacteria P. aeruginosa
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10035664
    E.1.2Term Pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess the efficacy of Aerucin®, administered as a single dose in addition to standard
    antibiotic regimen, in terms of clinical cure at day 14, i.e., resolution of the P. aeruginosa
    pneumonia event diagnosed at enrollment, as compared to standard antibiotic therapy alone.
    2. To assess the clinical safety and tolerability of Aerucin® in the study population.
    1.Evaluar la eficacia de Aerucin®, administrado como dosis única en combinación con el régimen estándar de antibióticos, en términos de curación clínica y de acuerdo con la evaluación de un comité de adjudicación el día 14; es decir, la resolución de un evento de neumonía por P.aeruginosa diagnosticado en el momento de la inclusión, en comparación con el tratamiento estándar solo de antibióticos.
    2.Evaluar la seguridad y la tolerabilidad de Aerucin® en la población del estudio
    E.2.2Secondary objectives of the trial
    -Clinical Efficacy Objectives:
    1.Clinical cure: Clinical cure rate at day 4,7,21,28,using the same criteria as for the
    primary efficacy objective.Time to clinical cure
    2.Mortality: All-cause mortality.Pneumonia-related mortality post-treatment as adjudicated
    by an independent, blinded committee
    3.Respiratory function assessment:Changes in PaO2/FiO2.Need for mechanical ventilator
    support
    4.Overall clinical status:Changes in SOFA score
    5.Health economics and well-being:antibiotic utilization, duration of: stay in the ICU,hospitalization, mechanical ventilation,intubation
    -Pharmacokinetics:PK Profile over the study follow-up period
    -Safety Objectives:To assess the immunogenicity of Aerucin®
    -Microbiological Efficacy Objectives
    1.Eradication of index P.aeruginosa at 4,7,14, 21, 28 days post-treatment
    2.Relapse defined as a reoccurrence of pneumonia due to P. aeruginosa within the 28-day follow-up period
    3.Reduction in bacterial load related to the index P. aeruginosa
    Obj. Eficacia clínica
    1.Curación clín:tasa de curación clín los días 4,7,21 y28, utilizando los criterios del obj 1io de eficacia.Tiempo de curación clín
    2.Mortalidad:por todas las causas. M. relacionada con la neumonía post. al tratamiento según adjudique un comité ciego independiente
    3.Evaluación de la función respiratoria:Cambios en PaO2/FiO2.Necesidad de asist por ventilación mecánica
    4.Estado clínico general:cambios en la escala SOFA
    5.Economía de salud y bienestar:uso de antibióticos, duración en:la UCI;la hospitalización;la ventilación mecánica;la intubación
    -Farmacocinética:perfil farmacocinético (PK) en periodo de seguimiento
    -Obj de seguridad:evaluar la inmunogenicidad de Aerucin®
    -Obj. Eficacia microbiológica
    1.Erradicación del Ind. de P. aeruginosa los días 4,7,14,21 y28 post tratamiento
    2.Se define recaída como recurrencia de neumonía debido a P. aeruginosa los 28 días del periodo de seguimiento
    3.Red. de carga bacteriana relacionada con el Ind. de P. aeruginosa
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written Informed Consent given by the patient or, if not possible, by a legally authorized representative and/or an independent physician as authorized by the competent ethics committee (EC) or independent review board (IRB) and local regulations.
    2. Diagnosis of pneumonia based on the following criteria:
    a. A sequence of at least 2 chest X-rays showing the presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia or 1 definitive chest X-ray diagnostic of pneumonia
    b. Hypoxemia based on at least one of the following criteria:
    i. PaO2/FiO2 <250
    ii. PaO2 <60 mmHg
    c. At least one of the following signs:
    i. Documented fever (e.g., body temperature greater than or equal to 38º Celsius).
    ii. Hypothermia (e.g., core body temperature less than or equal to 35º Celsius).
    iii. Total peripheral white blood cell (WBC) count greater than or equal to 10,000 cells/μL (or mm3).
    iv. Leukopenia with total WBC less than or equal to 4,500 cells/μL (mm3).
    v. Greater than 15 percent immature neutrophils (bands) noted on peripheral blood smear.
    3. To be at least 18 years of age.
    4. To be treated in an ICU at the time of enrollment.
    5. Endotracheal tube in place (tracheostomy is allowed),
    6. The patient is mechanically ventilated.
    7. Documented pulmonary infection with P. aeruginosa obtained by BAL, mini-BAL, protected endotracheal tube aspiration (ETA). For the purpose of randomization, P. aeruginosa must be identified either by:
    a. On the basis of available results from a culture positive by any method for P. aeruginosa of a sample obtained less than 72 hours prior to randomization. In such case, a fresh sample must be obtained prior to treatment initiation for standard microbial culture by the local laboratory (including organism identification, quantitative culture and susceptibility testing); the corresponding culture results are not required prior to randomization.
    OR
    b. On the basis of a rapid diagnostic test (see section 14.3 for allowed methods). In such case, the same sample must be used for standard microbial culture by the local laboratory (including organism identification, quantitative culture and susceptibility testing). The corresponding culture results are not required prior to randomization.
    8. APACHE II score ≥ 10 and ≤ 35 within 24 hours of enrollment
    1. Consentimiento informado por escrito proporcionado por el paciente o, en caso de que esto no sea posible, por un representante autorizado legalmente y/o un médico independiente autorizado por el comité de ética competente (CE) o por el comité de revisión independiente (CRI) y por las normas locales.
    2. Diagnóstico de neumonía de acuerdo con los siguientes criterios:
    a. Una secuencia de al menos 2 radiografías de tórax que muestren la presencia de uno o más infiltrados nuevos o progresivos que sugieran la presencia de neumonía bacteriana o 1 radiografía de tórax definitiva que diagnostique neumonía.
    b. Hipoxemia basada en al menos uno de los siguientes criterios:
    i. PaO2/FiO2 <250.
    ii. PaO2 <60 mmHg.
    c. Al menos uno de los siguientes signos:
    i. Fiebre documentada (por ejemplo, con temperatura corporal mayor o igual que 38 grados Celsius).
    ii. Hipotermia (por ejemplo, con temperatura corporal central menor o igual que 35 grados Celsius).
    iii. Recuento total de glóbulos blancos (GB) periféricos mayor o igual que 10.000 células/μl (o mm3).
    iv. Leucopenia con un total de GB menor o igual que 4500 células/μl (mm3).
    v. Identificación de más del 15% de neutrófilos inmaduros (bandas) en el frotis de sangre periférica.
    3. Tener al menos 18 años.
    4. Recibir tratamiento en una UCI en el momento de la inclusión.
    5. Tubo endotraqueal colocado (se permite traqueotomía).
    6. Paciente con asistencia por ventilación mecánica.
    7. Infección pulmonar documentada con P. aeruginosa obtenida por lavado broncoalveolar (LBA), minilavado broncoalveolar (mini-LBA), aspiración por tubo endotraqueal protegido (ETA). A efectos de la aleatorización, la bacteria P. aeruginosa debe identificarse siguiendo alguno de los siguientes criterios:
    a. De acuerdo con los resultados disponibles de un cultivo positivo obtenido mediante cualquier método para detectar la bacteria P. aeruginosa en una muestra obtenida al menos 72 horas antes de la aleatorización. En ese caso, el laboratorio local debe obtener una muestra reciente antes del inicio del tratamiento para el cultivo microbiano estándar (lo que incluye los procesos de identificación del organismo, cultivo cuantitativo y prueba de susceptibilidad). No se necesitan los resultados correspondientes al cultivo antes de la aleatorización.
    O
    b. De acuerdo con una prueba de diagnóstico rápida (consulte los métodos permitidos en la sección 14.3). En ese caso, el laboratorio local deberá utilizar la misma muestra para el cultivo microbiano estándar (lo que incluye los procesos de identificación del organismo, cultivo cuantitativo y prueba de susceptibilidad). No se necesitan los resultados correspondientes al cultivo antes de la aleatorización.
    8. Puntuación APACHE II ≥10 y ≤35 dentro de las 24 horas de la inclusión.
    E.4Principal exclusion criteria
    1. The subject is moribund.
    2. Effective antibacterial drug therapy for the index pneumonia administered continuously for 48 hours or more prior to initiation of study treatment.
    3. Plasmapheresis (ongoing or planned)
    4. Immunocompromised and at risk of infection by opportunistic pathogens including, but not limited to the following:
    a. HIV / AIDS who are not stable under medication and/or most recent CD4 <200
    b. Expected neutropenia due to chemotherapy
    c. Absolute neutrophil count less than 500/μL (mm3)
    d. Heart or lung transplant recipient within the past 6 months
    5. Known hereditary complement deficiency.
    6. Liver function deficiency associated with chronic conditions (e.g., liver cirrhosis Child- Pugh C).
    7. Pulmonary disease that precludes evaluation of a therapeutic response (such as lung cancer resulting in bronchial obstruction or on the same side as the pneumonia, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection, lung abscess, pleural empyema or post obstructive pneumonia)
    8. Administration of anti-infective monoclonal antibody within 3 months prior to enrollment.
    9. Women of childbearing potential who are sexually active and have not been using a medically acceptable method contraception for at least 12 months and in whom a pregnancy test is either not available or positive at the time of enrollment. Women who are surgically sterile or sterile for any other reason are eligible provided medical evidence is provided and maintained in the study file. Women who are post-menopausal as evidenced by the absence of menstruation for at least 1 year are eligible; the date of the last menstruation is to be recorded in the study file unless postmenopausal status is obvious due to age.
    10. Known lack of treatment compliance from prior studies or ongoing medical care based on medical records and Principal Investigator’s judgment and/or the capacity of the patient to comply with all study requirements.
    11. Any medical, psychological, cognitive, social or legal conditions that would interfere in the ability to give an Informed Consent OR the absence of a legally valid representative of the patient or independent physician allowed and able to give consent on his/her behalf.
    12. Participation as subject in another interventional study within 30 days prior to the first dose of study treatment, or planned participation in such a study during the study or within 30 days of its completion by the patient. Patients who participate in observational or epidemiological studies are eligible provided this does not interfere with their capacity or the capacity of the study staff to comply with all study requirements.
    1. Sujeto en fase terminal.
    2. Terapia efectiva con medicamentos antibacterianos para el índice de neumonía administrado en forma continua durante 48 horas o más antes del inicio del tratamiento del estudio.
    3. Plasmaféresis (en curso o planificada).
    4. Paciente inmunocomprometido o con riesgo de presentar una infección provocada por patógenos oportunistas, que incluyen, pero no se limitan a los siguientes:
    a. VIH o SIDA inestables aún bajo medicación y/o con células CD4 < 200 más recientes.
    b. Neutropenia probable provocada por quimioterapia.
    c. Recuento absoluto de neutrófilos inferior a 500/μl (mm3).
    d. Receptor de trasplante de corazón o pulmón en los 6 meses previos a la inclusión.
    5. Conocimiento de deficiencia hereditaria del complemento.
    6. Deficiencia hepática asociada con enfermedades crónicas (por ejemplo, cirrosis hepática clasificada como clase C según la escala de Child-Pugh).
    7. Enfermedad pulmonar que imposibilita la evaluación de una respuesta terapéutica (como cáncer de pulmón que deriva en una obstrucción bronquial o que se produce en el mismo lado que la neumonía, tuberculosis activa, fibrosis quística, enfermedad granulomatosa, infección pulmonar micótica, absceso pulmonar, empiema pleural o neumonía post-obstructiva).
    8. Administración de anticuerpo monoclonal anti-infeccioso en el plazo de los 3 meses previos a la inclusión.
    9. Mujeres con capacidad reproductiva, que sean sexualmente activas, que no hayan utilizado un método anticonceptivo médicamente aceptable durante al menos 12 meses y que no dispongan de un test de embarazo o que dispongan de un test de embarazo con resultado positivo en el momento de la inclusión en el estudio. Las mujeres estériles por procedimiento quirúrgico o estériles por cualquier otro motivo son elegibles siempre y cuando se proporcione evidencia médica que se mantenga en el archivo del estudio. Las mujeres posmenopáusicas, confirmado por la ausencia de menstruación durante al menos 1 año, son elegibles; la fecha de la última menstruación deberá registrarse en el archivo del estudio a menos que el estado posmenopáusico sea obvio por la edad.
    10. Conocimiento de la falta de cumplimiento del tratamiento en estudios anteriores o cuidados médicos en curso según expedientes médicos y el criterio del investigador principal y/o la capacidad del paciente para cumplir con todos los requisitos del estudio.
    11. Pacientes con cualquier condición médica, psicológica, cognitiva, social o legal que pueda interferir en su capacidad para otorgar un consentimiento informado O pacientes que no cuenten con la presencia de representantes legales válidos o de médicos independientes autorizados y con capacidad para dar el consentimiento en su nombre.
    12. Participación como sujeto en otros estudios intervencionistas en el plazo de los 30 días previos a la primera dosis del tratamiento del estudio, o participación planificada en dichos estudios durante el desarrollo de este estudio o en el plazo de 30 días de la finalización por parte del paciente. Los pacientes que participan en estudios observacionales o epidemiológicos son aptos para participar en este estudio siempre y cuando no interfieran con su capacidad o la capacidad del personal del estudio para cumplir con todos los requisitos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical cure, relapse ( pneumonia due to P. aeruginosa), or reinfection (pneumonia due to a pathogen other than P. aeruginosa)
    Curación clínica, recaída (neumonía debido a P. aeruginosa) o reinfección (neumonía debido a otro patógeno que no sea P. aeruginosa)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical cure, i.e., resolution of the pneumonia event diagnosed at enrollment. “Clinical cure” is resolution of pneumonia as determined by an independent adjudication committee based on objective criteria. Clinical cure at day 14 will be used as primary clinical efficacy parameter.
    Curación clínica; es decir, la resolución del evento de neumonía diagnosticado en el momento de la inclusión en el estudio. La “curación clínica” es la resolución de la neumonía de acuerdo con lo determinado por un comité de adjudicación independiente según criterios objetivos. La curación clínica en el día 14 se utilizará como parámetro primario de eficacia clínica.
    E.5.2Secondary end point(s)
    Secondary Clinical Efficacy Parameters
    1. Clinical cure:
    - Clinical cure rate at day 4, 7, 21 and 28.
    - Time to clinical cure.
    2. Mortality:
    - All-cause mortality
    - Pneumonia-related mortality
    - Time to death over the 28-day follow-up period.
    3. Respiratory function assessment: PaO2/FiO2
    4. Overall clinical status: SOFA
    5. Health economics and well-being: antibiotic utilization, duration of stay in the ICU,
    duration of hospitalization, ventilator-free days.
    Microbiological Endpoints
    1. Curación clínica:
    - Tasa de curación clínica en los días 4, 7, 21 y 28.
    - Tiempo de curación clínica.
    2. Mortalidad:
    - Mortalidad por todas las causas.
    - Mortalidad relacionada con la neumonía.
    - Momento del fallecimiento durante el periodo de seguimiento de 28 días.
    3. Evaluación de la función respiratoria: PaO2/FiO2.
    4. Estado clínico general: SOFA
    5. Economía de la salud y bienestar: uso de antibióticos, duración de la estancia en la UCI,duración de la hospitalización, días sin ventilación mecánica.
    Criterios de valoración microbiológicos
    E.5.2.1Timepoint(s) of evaluation of this end point
    The clinical course of pneumonia will be assessed daily by the investigator.
    Secondary endpoints will be assessed for analytical purposes on day 4, 7, 14, 21 and 28.
    El curso clínico de la neumonía será evaluado diariamente por el investigador.
    Criterios de valoración secundarios serán evaluados para propósitos analíticos los días 4, 7, 14, 21 y 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 No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Belgium
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Italy
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Taiwan
    United Kingdom
    United States
    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
    LPLV
    UVUP (Ultima Visita del Ultimo 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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial 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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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
    When patients are intubated and not able to provide consent, the consent or the approval will be provided according to the local law specific for the country (by LAR, court, independent physician etc).
    Cuando los pacientes están intubados y no puedan dar su consentimiento, el consentimiento o la aprobación se proporcionará de acuerdo con la legislación especifica del país (Representante Legal, Tribunal, o médico independiente, etc)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 108
    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
    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 Decision2017-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-25
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