Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-004703-23
    Sponsor's Protocol Code Number:1424R2131
    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:2016-12-12
    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 number2015-004703-23
    A.3Full title of the trial
    A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
    Estudio clínico multicéntrico, aleatorizado y abierto de S-649266 o mejor tratamiento disponible para infecciones graves provocadas por patógenos gram negativos resistentes a carbapenemos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
    Estudio de S-649266 o mejor terapia disponible para el tratamiento de infecciones graves provocadas por patógenos gram negativos resistentes a carbapenemos
    A.3.2Name or abbreviated title of the trial where available
    CREDIBLE
    A.4.1Sponsor's protocol code number1424R2131
    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 SponsorShionogi Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportShionogi & Co., Ltd
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShionogi & Co., Ltd
    B.5.2Functional name of contact pointCorporate Communications Department
    B.5.3 Address:
    B.5.3.1Street Address1-8, Doshomachi 3-chome
    B.5.3.2Town/ cityChuo-ku, Osaka
    B.5.3.3Post code541-0045
    B.5.3.4CountryJapan
    B.5.4Telephone number900 811 335
    B.5.6E-mailshionogiclintrials-admin@shionogi.co.jp
    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.3.2Product code S-649266
    D.3.4Pharmaceutical form Powder 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 INNNA
    D.3.9.3Other descriptive nameS-649266
    D.3.9.4EV Substance CodeSUB131099
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Hospital acquired pneumonia (HAP)/ventilator associated pneumonia (VAP)/healthcare-associated pneumonia (HCAP) or bloodstream infections/sepsis (BSI/sepsis) caused by carbapenem-resistant Gram-negative pathogens.
    Complicated urinary tract infection (cUTI) caused by carbapenem-resistant Gram-negative pathogens.
    Neumonía adquirida en el hospital (NAH)/neumonía asociada a ventiloterapia (NAV)/neumonía asociada a la atención médica (NAAT) o infección del torrente sanguíneo/sepsis (ITS/sepsis) causadas por patógenos gram negativos resistentes a carbapenemos.
    infección del tracto urinario complicadas (ITUc) causadas por patógenos gram negativos resistentes a carbapenemos.
    E.1.1.1Medical condition in easily understood language
    Severe infections caused by Carbapenem-resistant Gram-negative pathogens.
    infecciones graves provocadas por patógenos gram negativos resistentes a carbapenemos
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10076918
    E.1.2Term Hospital acquired pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10065153
    E.1.2Term Ventilator associated pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level HLT
    E.1.2Classification code 10046577
    E.1.2Term Urinary tract infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    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, at test of cure (TOC), the clinical outcome of treatment with S-649266 or best available therapy (BAT) in adult patients with either hospital acquired pneumonia (HAP)/ventilator associated pneumonia (VAP)/healthcare-associated pneumonia (HCAP) or bloodstream infections/sepsis (BSI/sepsis) caused by carbapenem-resistant Gram-negative pathogens
    -To assess, at TOC, the microbiologic outcome of treatment with S-649266 or BAT in adult patients with complicated urinary tract infection (cUTI) caused by carbapenem-resistant Gram-negative pathogens
    - Evaluar, en la confirmación de la curación (CDC), el desenlace clínico del tratamiento con S-649266 o mejor tratamiento disponible (MTD) en pacientes adultos con neumonía adquirida en el hospital (NAH)/neumonía asociada a ventiloterapia (NAV)/neumonía asociada a la atención médica (NAAT) o infección del torrente sanguíneo/sepsis (ITS/sepsis) causadas por patógenos gram negativos resistentes a carbapenemos
    -Evaluar, en la CDC, el desenlace microbiológico del tratamiento de S-649266 o MTD en pacientes adultos con infección del tracto urinario complicadas (ITUc) causadas por patógenos gram negativos resistentes a carbapenemos
    E.2.2Secondary objectives of the trial
    Safety of S-649266
    Clinical outcome of treatment with S-649266 or BAT in patients with HAP/VAP/HCAP or BSI/sepsis and with cUTI (TOC/EOT)
    Microbiologic outcome of treatment with S-649266 or BAT in patients with either HAP/VAP/HCAP or BSI/sepsis, with cUTI and with bacteremia (EOT/TOC/FU)
    Composite clinical and microbiologic outcome of S-649266 or BAT in patients with cUTI
    All-cause mortality at Day 14 and Day 28 in patients with HAP/VAP/HCAP and BSI/sepsis
    Relationship between the PD parameter %Tf >MIC based on plasma drug concentrations at steady state and the clinical and microbiologic outcomes of treatment with S-649266 in patients with HAP/VAP/HCAP, cUTI, or BSI/sepsis
    Resource utilization required for the treatment of the study qualifying infection
    To compare S-649266 with BAT in patients with HAP/VAP/HCAP, cUTI, or BSI/sepsis on the composite endpoint of Survival and no change in antibiotic treatment due to lack of therapeutic benefit or drug-related toxicity
    Seguridad de S-649266
    Desenlace clínico del tratamiento con S-649266 o MTD en pacientes con NAH/NAV/NAAT o ITS/sepsis y con ITUc (CDC/FDT)
    Desenlace microbiológico de S-649266 o MTD en pacientes con NAH/NAV/NAAT o ITS/sepsis, con ITUc y bacteriemia (FDT/CDC/SEG)
    Desenlace del compuesto clínico y microbiológico de S-649266 o MTD en pacientes con ITUc
    Mortalidad el día 14 y el día 28 en pacientes con NAH/NAV/NAAT e ITS/sepsis
    Relación entre el parámetro FD %Tf>CMI basado en las concentraciones plasmáticas del fármaco en equilibrio y los desenlaces clínico y microbiológico del tratamiento con S-649266 en pacientes con NAH/NAV/NAAT, ITUc o ITS/sepsis
    Recursos para el tratamiento de la infección objeto del estudio
    Comparar S-649266 con MTD en pacientes con NAH/NAV/NAAT, ITUc o ITS/sepsis según el criterio de valoración compuesto de supervivencia y falta de cambios en el tratamiento con antibióticos por la falta de ventaja terapéutica o la toxicidad relacionada con el fármaco
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria:
    Patients who fulfill the following criteria at Screening will be included in the study:
    1. Hospitalized male and female patients, 18 years or older at the time of signing
    informed consent
    2. Patients who have provided written informed consent or their informed consent
    was provided by legal guardian. (Note: Country specific rules and local Ethics
    Committee approval for legal guardian informed consent will determine whether
    or not and how a patient unable to comprehend or sign the informed consent is
    allowed to be enrolled in the study)
    3. Patients with clinically documented infection (HAP/VAP/HCAP, cUTI, or
    BSI/sepsis) caused by a Gram-negative pathogen with evidence of carbapenem
    resistance
    4. Patients who have been treated previously with an empiric antibiotic regimen and
    failed treatment, both clinically and microbiologically, are eligible for the study, if
    they have an identified carbapenem-resistant , Gram-negative pathogen which has
    either been shown to be nonsusceptible in vitro to each of the antibiotic(s) of the
    empiric antibiotic regimen or been grown from a culture performed after at least
    two days of the empiric antibiotic regimen
    5. Patient is male (no contraception required) or female and meets one of the
    following criteria:
    - Surgically sterile by hysterectomy and/or bilateral oophorectomy or bilateral
    salpingectomy or tubal ligation for the purpose of contraception for at least 6
    weeks with appropriate documentation of such surgery
    - Postmenopausal (defined as older than 45 years of age with cessation of
    regular menstrual periods for 6 months and confirmed by a follicle-stimulating
    hormone level of > 40 mIU/ml, or amenorrhea for at least 12 months)
    - Of childbearing potential and using combined (estrogen and progestogen) or
    progestogen-only hormonal contraception associated with inhibition of
    ovulation (including oral, intravaginal, injectable, implantable, and
    transdermal contraceptives), or an intrauterine device (IUD), or intrauterine
    hormone-releasing system (IUS) for the entire duration of the study
    - Of childbearing potential and practice abstinence as a preferred and usual
    lifestyle, and agrees to continue practicing abstinence from screening up to 14
    days after the last dose of study drug
    - Of childbearing potential, whose sole heterosexual partner has been successfully vasectomized and agrees to not have other heterosexual partners
    for the entire duration of the study
    6. Patients meeting specific inclusion criteria for each infection site (See Diagnosis-
    Specific Inclusion Criteria)
    Criterios de inclusión generales
    Se incluirán en el estudio los pacientes que cumplan los criterios siguientes:
    1. Pacientes hospitalizados, hombres y mujeres, mayores de 18 años en el momento de firmar el consentimiento informado.
    2. Pacientes que hayan dado su consentimiento informado por escrito o cuyo consentimiento informado fue proporcionado por su tutor legal. (Nota: la autorización para inscribir o no en el estudio a los pacientes incapaces de firmar o comprender el consentimiento informado y cómo vendrá determinada por las normas específicas de cada país y la aprobación del consentimiento informado del tutor legal por parte del Comité de ética local).
    3. Pacientes con infección documentada clínicamente (NAH/NAV/NAAT, ITUc o ITS/sepsis), causada por un patógeno gram negativo con evidencia de resistencia a carbapenemos.
    4. Los pacientes que hayan sido tratados previamente con una pauta empírica de antibióticos y no hayan respondido al tratamiento, tanto clínica como microbiológicamente, son idóneos para el estudio si padecen un patógeno identificado gram negativo resistente a carbapenemos que haya resultado no ser susceptible in vitro a cada uno de los antibióticos de la pauta empírica de antibióticos o que haya crecido en un cultivo realizado al menos dos días después de la pauta empírica de antibióticos.
    5. El paciente es hombre (no necesita anticoncepción) o mujer que cumple uno de los criterios siguientes:
    - Quirúrgicamente estéril por histerectomía y/o ooforectomía bilateral o salpingectomía o ligadura de trompas bilateral con propósito anticonceptivo durante al menos 6 semanas, con documentación adecuada de tal cirugía
    - Postmenopáusica (definida como mayor de 45 años de edad con cese de los periodos menstruales normales durante 6 meses y confirmada por un nivel de hormona foliculoestimulante de > 40 mIU/ml o amenorrea durante al menos 12 meses)
    - Tiene capacidad para quedar embarazada y utiliza anticoncepción hormonal combinada (estrógeno y progesterona) o solamente progesterona asociada a la inhibición de la ovulación (incluidos anticonceptivos orales, intravaginales, inyectables, implantables y transdérmicos) o un dispositivo intrauterino (DIU) o un sistema de liberación de hormonas intrauterino (SIU) a lo largo de toda la duración del estudio
    - Tiene capacidad para quedar embarazada y practica la abstinencia como estilo de vida preferido y habitual, acepta continuar practicando la abstinencia desde la selección hasta 14 días después de la última dosis de fármaco del estudio
    - Tiene capacidad para quedar embarazada, su único compañero heterosexual se ha sometido con éxito a una vasectomía, y acepta no tener otros compañeros heterosexuales a lo largo de toda la duración del estudio
    6. Pacientes que cumplan criterios de inclusión específicos para cada punto de infección (consulte los criterios de inclusión específicos del diagnóstico)
    E.4Principal exclusion criteria
    General Exclusion Criteria:
    Patients who meet any of the following criteria at Screening will be excluded from the study:
    1.Patients who have a documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam (Note: for β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment)
    2.Patients with severe neutropenia, ie, polymorphonuclear neutrophils (PMNs) < 100 cells/μL
    3.Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score > 30
    4.Patients with any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the study data
    5.Patients meeting specific exclusion criteria for each infection site
    Criterios de exclusión generales:
    Los pacientes que cumplan cualquiera de los siguientes criterios en la selección se excluirán del estudio:
    1. Pacientes que tengan antecedentes documentados de hipersensibilidad o reacción alérgica moderada o intensa a cualquier β-lactámico (Nota: para los β-lactámicos, los antecedentes de erupción leve seguida por una nueva exposición sin incidentes no constituye una contraindicación para la inscripción)
    2. Pacientes con neutropenia intensa, p. ej. neutrófilos polimorfonucleares (PMN) < 100 células/µl
    3. Pacientes con puntuación APACHE II (acute physiology and chronic health evaluation II) > 30
    4. Pacientes con cualquier afección o circunstancia que, en opinión del investigador, suponga un riesgo para la seguridad del paciente o la calidad de los datos del estudio
    5. Pacientes que cumplan criterios de exclusión específicos para cada punto de infección
    E.5 End points
    E.5.1Primary end point(s)
    -Clinical outcome per patient at TOC in patients with HAP/VAP/HCAP or BSI/sepsis
    -Microbiologic outcome (for Gram-negative pathogen) per patient at TOC in patients with cUTI
    -Desenlace clínico por paciente en CDC en pacientes con NAH/NAV/NAAT o ITS/sepsis
    -Desenlace microbiológico (para patógeno gram negativo) por paciente en CDC en pacientes con ITUc
    E.5.1.1Timepoint(s) of evaluation of this end point
    Test of cure (TOC) - EOT + 7 days
    Confirmación de la curación (CDC) - FDT + 7 días
    E.5.2Secondary end point(s)
    -Clinical outcome per patient at EOT (HAP/VAP/HCAP or BSI/sepsis)
    -Clinical outcome per pathogen at EOT, and TOC (HAP/VAP/HCAP or BSI/sepsis)
    -Clinical outcome per patient/pathogen at EOT, and TOC (cUTI)
    -Microbiologic outcome (for Gram-negative pathogen) per patient/pathogen at EOT, TOC, and FUP (HAP/VAP/HCAP or BSI/sepsis)
    -Microbiologic outcome (for Gram-negative pathogen) per patient at EOT, and FUP (cUTI)
    -Microbiologic outcome (for Gram-negative pathogen) per pathogen at EOT, TOC, and FUP (cUTI)
    -Microbiologic outcome with documented carbapenem-resistant Gram-negative bacteremia (regardless of primary infection diagnosis) at EOT, TOC, and FUP
    -Composite clinical and microbiologic outcome at EOT, and TOC (cUTI only)
    -All-cause mortality at Day 14 and Day 28 for HAP/VAP/HCAP and BSI/sepsis
    -Composite endpoint of survival and no change in antibiotic treatment due to either lack of therapeutic benefit or drug-related toxicity at TOC
    -Survival time (HAP/VAP/HCAP, BSI/sepsis)
    -CPIS parameters at EOT and TOC (HAP/VAP/HCAP only)
    -SOFA Score at EOT, and TOC
    - Desenlace clínico por paciente en FDT (NAH/NAV/NAAT o ITS/sepsis)
    - Desenlace clínico por patógeno en FDT y CDC (NAH/NAV/NAAT o ITS/sepsis)
    - Desenlace clínico por paciente/patógeno en FDT y CDC (ITUc)
    - Desenlace microbiológico (para patógeno gram negativo) por paciente/patógeno en FDT, CDC y SEG (NAH/NAV/NAAT o ITS/sepsis)
    - Desenlace microbiológico (para patógeno gram negativo) por paciente en FDT y SEG (ITUc)
    - Desenlace microbiológico (para patógeno gram negativo) por patógeno en FDT, CDC y SEG (ITUc)
    - Desenlace microbiológico con bacteriemia gram negativa resistente a carbapenemos documentada (independientemente del diagnóstico de infección primario) en FDT, CDC y SEG
    - Desenlace compuesto clínico y microbiológico en FDT y CDC (solamente ITUc)
    - Mortalidad por cualquier causa el día 14 y el día 28 para NAH/NAV/NAAT e ITS/sepsis
    - Criterio de valoración compuesto de supervivencia y ausencia de cambios en el tratamiento con antibióticos debido a la falta de ventaja terapéutica o toxicidad relacionada con el fármaco en CDC
    - Tiempo de supervivencia (NAH/NAV/NAAT, ITUc o ITS/sepsis)
    - Parámetros PIPC en FDT y CDC (solamente NAH/NAV/NAAT)
    - Puntuación SOFA en FDT y CDC
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of treatment (EOT) - Last day of study therapy
    Test of cure (TOC) - EOT + 7 days
    Follow-up (FUP) - EOT + 14 days
    Finalización del tratamiento (FDT) - Último día de tratamiento del estudio
    Confirmación de la curación (CDC) - FDT + 7 días
    Seguimiento (SEG) - FDT + 14 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    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
    Brazil
    Colombia
    Croatia
    France
    Germany
    Greece
    Guatemala
    Israel
    Italy
    Japan
    Korea, Republic of
    Spain
    Taiwan
    Thailand
    Turkey
    United Kingdom
    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
    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 months10
    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 months10
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 150
    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)
    Patients withdrawn or discontinued from study treatment should receive additional standard of care antibiotic therapy if in the judgment of the investigator such treatment is clinically indicated.
    Los pacientes que se retiren o a los que se les suspenda el tratamiento del estudio deben recibir la terapia habitual si, a juicio del investigador, tal tratamiento está clínicamente indicado
    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 Decision2017-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-22
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 14:09:35 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA