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    Summary
    EudraCT Number:2018-001476-37
    Sponsor's Protocol Code Number:HUB-INF-BEATLE-403
    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:2019-04-11
    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 number2018-001476-37
    A.3Full title of the trial
    Efficacy of extended infusion of β-lactam antibiotics for the treatment of febrile neutropenia in hematologic patients (BEATLE study).
    Eficacia de la infusión extendida de los antibióticos β-lactámicos en el tratamiento de la neutropenia febril en los pacientes hematológicos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of extended infusion of β-lactam antibiotics for the treatment of febrile neutropenia in hematologic patients (BEATLE study).
    Eficacia de la infusión extendida de los antibióticos β-lactámicos en el tratamiento de la neutropenia febril en los pacientes hematológicos.
    A.4.1Sponsor's protocol code numberHUB-INF-BEATLE-403
    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 SponsorDra. Carlota Gudiol González. Servicio de Enfermedades Infecciosas. Hospital Universitari de Bellvitge.
    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 supportFondos de Investigación Sanitarias (FIS) INSTITUTO CARLOS III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDra. Júlia Laporte Amargós. Servicio de Enfermedades Infecciosas. Hospital Universitari de Bellvitge
    B.5.2Functional name of contact pointDra. Júlia Laporte Amargós
    B.5.3 Address:
    B.5.3.1Street AddressCalle Feixa Llarga, s/n
    B.5.3.2Town/ cityL'Hospitalet de Llobregat
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number34932607625
    B.5.5Fax number34932607637
    B.5.6E-mailjulia_laporte@hotmail.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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namePiperacilina
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNPIPERACILLIN
    D.3.9.1CAS number 66258-76-2
    D.3.9.2Current sponsor codePIPERACILLIN
    D.3.9.3Other descriptive namePIPERACILLIN
    D.3.9.4EV Substance CodeSUB09867MIG
    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 RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTazobactam
    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 INNTAZOBACTAM
    D.3.9.1CAS number 89786-04-9
    D.3.9.2Current sponsor codeTAZOBACTAM
    D.3.9.3Other descriptive nameTAZOBACTAM
    D.3.9.4EV Substance CodeSUB10849MIG
    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: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCefepime
    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 INNCEFEPIME
    D.3.9.1CAS number 88040-23-7
    D.3.9.2Current sponsor codeCEFEPIME
    D.3.9.3Other descriptive nameCEFEPIME
    D.3.9.4EV Substance CodeSUB07390MIG
    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: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameMeropenem
    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 INNMEROPENEM
    D.3.9.1CAS number 96036-03-2
    D.3.9.2Current sponsor codeMEROPENEM
    D.3.9.3Other descriptive nameMEROPENEM
    D.3.9.4EV Substance CodeSUB08778MIG
    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
    Febrile neutropenia is the presence of fever in compramised immune activity in patients with hematologic disease. In which case, an antibiotic must be started.
    La neutropenia febril es la aparición de fiebre en contexto de defensas bajas en pacientes con enfermedad hematológica. En este caso está indicado el inicio de tratamiento antibiótico.
    E.1.1.1Medical condition in easily understood language
    Febrile neutropenia is the presence of fever in compramised immune activity in patients with hematologic disease. In which case, an antibiotic must be started.
    La neutropenia febril es la aparición de fiebre en contexto de defensas bajas en pacientes con enfermedad hematológica. En este caso está indicado el inicio de tratamiento antibiótico.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10029357
    E.1.2Term Neutropenia malignant
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the clinical efficacy of extended infusion (EI) of BLA in the patient with febrile neutropenia.
    Estudiar la eficacia clínica de la administración en IE de ABL en el paciente con neutropenia febril
    E.2.2Secondary objectives of the trial
    1) Clinical Objectives:

    1.1)To determine if the administration of BLA in EI is superior to the administration in II in reaching the PK/PD target in hematological patients with febrile neutropenia.

    1.2)To determine if the administration of BLA in EI is superior to the administration in II, defined by the time to the normalization/significant decrease in the inflammatory biomarkers.

    1.3)To determine the 30-day overall case-fatality rate of the study population, according to therapy group.

    1.4)Develop a pharmacokinetic / pharmacodynamic model to optimize BLA treatment in patients with febrile neutropenia

    2)Microbiological Objective:

    2.1)To determine if the administration of BLA in EI is superior to the administration in II in the rapidity of negativization of blood cultures in patients with bacteremia.

    3)Security Objectives:

    3.1)PENDIENTE DE TRADUCIR
    1) Objetivos Clínicos:

    1.1)Determinar si la administración en IE de los ABL es superior a la administración en II a nivel farmacocinético.

    1.2)Determinar si la administración en IE de los ABL disminuye más rápidamente los reactantes de fase aguda respecto a la II.

    1.3)Determinar la mortalidad global (por cualquier causa) a los 30 días de haber iniciado el tratamiento.

    1.4)Desarrollar un modelo farmacocinético/farmacodinámico poblacional para optimizar los tratamientos ABL en pacientes con neutropenia febril.

    2)Objetivo Microbiológico:

    2.1)Determinar el tiempo hasta negativizar los hemocultivos en aquellos pacientes con bacteriemia.

    3) Objetivos de Seguridad:

    3.1)Evaluar la seguridad de la administración en IE comparada con la administración en II.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    We aim to perform a population pharmacokinetic study for each antibiotic. Pharmacokinetic studies consist on the evaluation of the concentration of the antibiotic in blood over time. This data will be analyzed to create a model to predict the best administrations of the ABL to patients with febrile neutropenia. This is the reason why to 2-3 more blood samples will be required.
    The substudy will include 45 patients from a single center, the Institut Català Oncologia (ICO) Hospitalet.
    Realizar un estudio de farmacocinética poblacional para cada antibiótico.Este estudio farmacocinético consiste en la valoración de la concentración del antibiótico en sangre a lo largo del tiempo, para posteriormente analizar estos datos y poderlos aplicar de forma global a los pacientes con neutropenia febril. Para ello será necesario que se le extraigan 2-3 muestras adicionales a las que se obtendrían por la práctica clínica habitual

    El subestudio incluirá 45 pacientes en un único centro, el Institut Català Oncologia (ICO) Hospitalet
    E.3Principal inclusion criteria
    1)Adult patients (age ≥18 years) of both sexes

    2)Patients admitted in Hematological ward

    3) With any of the following diagnoses:
    3.1)Acute leukemia undergoing induction or consolidation chemotherapy
    3.2)Autologous or allogeneic hematopoietic stem cell transplant recipients

    4) With an episode of Febrile Neutropenia: ≥ 38.0ºC and <500 neutrophils / mm3 or <1000 with a predicted decrease within 24-48 hours

    5)Patient requires treatment with ABL: cefepime, piperacillin /tazobactam or meropenem, in monotherapy or in combination with another antibiotic.

    6)The patient or his legal representative grants their consent by signing the informed consent.
    1) Pacientes adultos (edad ≥18 años) de ambos sexos.

    2) Ingreso hospitalario en el Servicio de Hematología Clínica.

    3) Con alguno de los siguientes diagnósticos:
    3.1) Leucemia aguda en tratamiento de inducción o consolidación
    3.2) Receptores de un trasplante de progenitores hematopoyéticos autólogo o alogénico.

    4) Con episodio de Neutropenia Febril (<500 neutrófilos/mm3 o <1000 y previsión de rápido descenso en 24-48 horas y temperatura ≥38.0º).

    5) Paciente precisa de inicio de tratamiento con ABL: cefepime, piperacilina-tazobactam o meropenem, en monoterapia o en combinación con otro antibiótico.

    6) El sujeto o su representante legal otorgan su conformidad mediante la firma del consentimiento informado.
    E.4Principal exclusion criteria
    1) Allergy to study drugs

    2) Patient receiving systemic antibiotic treatment (except for prophylaxis) at the time of onset of febrile neutropenia.

    3) Absence of fever

    4) Patients with epilepsy

    5) Severe renal impairment (defined as creatinine clearance rate MDR / CKD-EPI <30 mL / min)

    6) Previously enrolled patients in whom the time between the inclusion and the current episode is less than 5 weeks

    7) Patients who have participated previously in this trial without current resolution of the first episode.
    1) Alergia a los fármacos de estudio.

    2) Paciente que estén en tratamiento antibiótico sistémico (a excepción de profilaxis) en el momento de inicio de la neutropenia febril.

    3) Ausencia de fiebre.

    4) Pacientes con epilepsia.

    5) Insuficiencia renal grave (definida como filtrado glomerular CKD-EPI <30 mL/min/1.73m2).

    6) Pacientes que hayan participado con anterioridad en este ensayo, y que sea el tiempo transcurrido desde la inclusión sea menor de 5 semanas.

    7) Pacientes que hayan participado con anterioridad en este ensayo sin resolución actual del primer episodio.
    E.5 End points
    E.5.1Primary end point(s)
    Number of responding patients. Responder is defined as a patient with defervescence (axillary temperature <37.5ºC, for 24 hours and documented in a minimum of 3 determinations, without reappearance of fever) during the first 5 days of treatment with ABL and without a modification of the antibiotic treatment.
    Número de pacientes respondedores. Se define respondedor como paciente que presenta defervescencia (temperatura axilar <37.5ºC, durante 24 horas y documentado en un mínimo de 3 determinaciones, sin reaparición de la fiebre) durante los 5 días de tratamiento con ABL, y sin modificación del tratamiento antibiótico
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the 5 days of treatment with ABL, and without modification of the antibiotic treatment.
    Durante los 5 días de tratamiento con ABL, y sin modificación del tratamiento antibiótico
    E.5.2Secondary end point(s)
    1) Clinical variables:
    1.1)Time (hours) until the defervescence, without a modification the antibiotic treatment.

    1.2)Number of patients that do not change the ABL treatment during the 5 days of study.

    1.3)Number of patients in which the PK / PD goal is reached, defined as antibiotic concentration time above a MIC of 50% (50% ft> MIC), 75% (75% ft> MIC) and 100% (100% ft> MIC) of the administration interval. In cases where there is a microbiological documentation, the determined MIC will be selected. Otherwise, the highest susceptible MIC for all likely organisms according to EUCAST2 will be selected (for P. aeruginosa: 16mg/L for piperacillin-tazobactam, 8mg/L for cefepime and 2mg/L for meropenem).

    1.4)Number of occasions per patient in which the PK / PD goal is reached, defined as antibiotic concentration time above a MIC of 50% (50% ft> MIC), 75% (75% ft> MIC) and 100% (100% ft> MIC) of the administration interval. In cases where there is a microbiological documentation, the determined MIC will be selected. Otherwise, the highest susceptible MIC for all likely organisms according to EUCAST2 will be selected (for P. aeruginosa: 16mg/L for piperacillin-tazobactam, 8mg/L for cefepime and 2mg/L for meropenem).

    1.5)Number of patients with clinical resolution of the infectious disease within 5 days and 30 days.

    1.6) Number of patients who normalize (<5 mg / dL C-reactive protein, (CRP); <0.1 mcg/dL procalcitonin) or decrease (50% of the maximum value) CRP and procalcitonin within the first 5 days of treatment.

    1.7) Time (days) until normalization / decrease of 50% of CRP.

    1.8) All-cause crude mortality at 30 days.

    1.9) A population pharmacokinetics substudy will be performed for each antibiotic

    2)Microbiologic criteria:
    2.1)Time (days) until negativization of blood cultures in patients with bacteremia.

    3)Security criteria:
    3.1) The incidence of adverse events according to seriousness and causality by treatment group
    1) Clínicas:

    1.1) Tiempo (en horas) hasta la defervescencia, sin modificar el tratamiento antibiótico.

    1.2) Número de pacientes que no se modifica el tratamiento ABL durante los 5 días de estudio.

    1.3) Número de pacientes en que se alcanza el objetivo PK/PD, definido como tiempo de concentración antibiótica por encima de la CMI en el 50% (50% ft>CMI), el 75% (75% ft>CMI) y el 100% (100% ft>CMI) del intervalo de administración. En los casos en que haya documentación microbiológica, se seleccionará la CMI determinada. En caso contrario, se seleccionará la CMI superior de sensibilidad para todos los posibles microorganismos para cada antibiótico de acuerdo con EUCAST2 (para P. aeruginosa: 16mg/L para piperacilina-tazobactam, 8mg/L para cefepime y 2mg/L para meropenem).

    1.4) Número de ocasiones por paciente en que se alcanza el objetivo PK/PD, definido como tiempo de concentración antibiótica por encima de la CMI en el 50% (50% ft>CMI), 75% (75% ft>CMI) y 100% (100% ft>CMI) del intervalo de administración. En los casos en que haya documentación microbiológica, se seleccionará la CMI determinada. En caso contrario, se seleccionará la CMI superior de sensibilidad para cada antibiótico de acuerdo con EUCAST2 (para P. aeruginosa: 16mg/L para piperacilina-tazobactam, 8mg/L para cefepime y 2mg/L para meropenem).

    1.5) Número de pacientes con resolución clínica del cuadro infeccioso a los 5 días y a los 30 días.

    1.6) Número de pacientes que normalizan (<5 mg/dL para proteína C-reactiva [PCR] y <0,1 mcg/dL para procalcitonina) o disminuyen (50% del valor máximo) los reactantes de fase aguda PCR y procalcitonina, en los primeros 5 días de tratamiento.

    1.7) Tiempo (en días) hasta la normalización/disminución del 50% de la PCR.

    1.8) Mortalidad cruda (por cualquier causa) a los 30 días.

    1.9) Se realizará un subestudio de farmacocinética poblacional para cada antibiótico.

    2) Microbiológicas:
    2.1) Tiempo (en días) hasta negativización de hemocultivos, en aquellos pacientes con bacteriemia.

    3) Seguridad:
    3.1) Incidencia de todos los acontecimientos adversos no esperados por la enfermedad de base o por su tratamiento y todos los acontecimientos adversos graves, según su gravedad y relación con el tratamiento, de la administración en IE comparada con la administración en II.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the 5 days of treatment with ABL, and without modification of the antibiotic treatment.
    Durante los 5 días de tratamiento con ABL, y sin modificación del tratamiento antibiótico
    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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Piperacilina/Tazabactam; Cefepime; Meropenem en II (Infusión intermitente)
    Piperacillin / Tazobactam; Cefepime; Meropenem in II (intermitent Infusion)
    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 concerned4
    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 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
    última visita del último sujeto incluido
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state150
    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 who complete their participation in this study will continue their follow-up at the discretion of their doctor according to the usual clinical practice.
    Los pacientes que finalicen su participación en este estudio, continuaran su seguimiento a criterio de su médico de acuerdo a la práctica clínica 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 Decision2019-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-28
    P. End of Trial
    P.End of Trial StatusOngoing
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