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    Summary
    EudraCT Number:2012-000726-21
    Sponsor's Protocol Code Number:D4280C00006
    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:2012-06-25
    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 number2012-000726-21
    A.3Full title of the trial
    An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens
    Estudio de fase III abierto, aleatorizado, multicéntrico de ceftazidima-avibactam (CAZ-AVI, antes CAZ104) y la mejor terapia disponible para el tratamiento de infecciones causadas por patógenos gramnegativos resistentes a ceftazidima
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Compare Ceftazidime Avibactam and Best Available Therapy for the treatment of infections
    Comparar ceftazidima-avibactam y la mejor terapia disponible para el tratamiento de infecciones
    A.4.1Sponsor's protocol code numberD4280C00006
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street AddressRoom Tatnall Bldg, 1800 Concord Pike, PO Box 15437
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19850-5437
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@astrazeneca.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 nameceftazidima avibactam
    D.3.2Product code CAZ AVI
    D.3.4Pharmaceutical form Powder for 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 INNPENTAHIDRATO DE CEFTAZIDIMA
    D.3.9.1CAS number 78439-06-2
    D.3.9.4EV Substance CodeSUB01134MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAVIBACTAM
    D.3.9.1CAS number 1192491-61-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.2.1.1.1Trade name Metronidazol
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namemetronidazol
    D.3.4Pharmaceutical form Solution for injection/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 INNMETRONIDAZOL
    D.3.9.1CAS number 443-48-1
    D.3.9.4EV Substance CodeSUB08922MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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.3.4Pharmaceutical form Powder for solution for injection/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 TRIHIDRATO
    D.3.9.1CAS number 119478-56-7
    D.3.9.4EV Substance CodeSUB21617
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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.3.4Pharmaceutical form Powder for solution for injection/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 INNCOLISTIMETATO DE SODIO
    D.3.9.1CAS number 8068-28-8
    D.3.9.4EV Substance CodeSUB06801MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2000000
    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: 5
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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.3.4Pharmaceutical form Powder for solution for injection/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 INNTIGECICLINA
    D.3.9.1CAS number 220620-09-7
    D.3.9.4EV Substance CodeSUB16467MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 6
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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.3.4Pharmaceutical form Powder for solution for injection/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 INNIMIPENEM MONOHIDRATO
    D.3.9.1CAS number 74431-23-5
    D.3.9.4EV Substance CodeSUB21472
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number530
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCILASTATINA SÓDICA
    D.3.9.1CAS number 81129-83-1
    D.3.9.4EV Substance CodeSUB01295MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number530
    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: 7
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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.3.4Pharmaceutical form Powder for solution for injection/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 INNMONOHIDRATO DE DORIPENEM
    D.3.9.1CAS number 364622-82-2
    D.3.9.4EV Substance CodeSUB32518
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    cUTI, Complicated Urinary Tract Infection, cIAI Complicated intra-abdominal infection
    IUc, infecciones urinarias complicadas; IIAc, infección intraabdominal complicada
    E.1.1.1Medical condition in easily understood language
    Urinary Tract Infection, abdominal infection
    Infecciones urinarias, infecciones intraabdominales
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the per-patient clinical response to ceftazidime-avibactam and best available therapy at TOC in the treatment of selected serious infections caused by ceftazidime-resistant Gram negative pathogens.
    Calcular la respuesta clínica por paciente a CAZ-AVI y a la mejor terapia disponible (MTD) en la visita de comprobación de la curación (CDC) en el tratamiento de determinadas infecciones graves causadas por patógenos gram negativos resistentes a la ceftazidima.
    E.2.2Secondary objectives of the trial
    - To evaluate the clinical response to CAZ-AVI and best available therapy at different visits and in patient subgroups
    - To estimate the microbiological response to CAZ-AVI and best available therapy in the treatment of selected serious infections caused by ceftazidime-resistant Gram-negative pathogens
    - To evaluate the reasons for treatment change and/or discontinuation for CAZ-AVI and best available therapy
    - To estimate the 28-day, all-cause mortality among patients treated with CAZ-AVI and best available therapy
    - To evaluate the safety and tolerability profile of CAZ-AVI and best available therapy for the treatment of selected serious infections caused by ceftazidime-resistant Gram negative pathogens
    - To evaluate the pharmacokinetics of the individual components of CAZ-AVI in this population with selected serious infections, and to characterize the relationship between the pharmacokinetics and clinical and microbiological response for CAZ-AVI
    - Evaluar más detenidamente la respuesta clínica a CAZ-AVI y a la MTD en visitas diferentes y en subgrupos de pacientes
    - Calcular la respuesta microbiológica a CAZ-AVI y a la MTD en el tratamiento de determinadas infecciones graves causadas por patógenos gramnegativos resistentes a la ceftazidima
    - Evaluar las razones del cambio de tratamiento y/o la retirada de CAZ-AVI y de la MTD
    - Calcular la mortalidad global a los 28 días en los pacientes tratados con CAZ-AVI y con la MTD.
    - Evaluar el perfil de seguridad y tolerabilidad de CAZ-AVI y de la MTD para el tratamiento de determinadas infecciones graves causadas por patógenos gram negativos resistentes a la ceftazidima
    - Evaluar la farmacocinética (FC) de los componentes individuales de CAZ-AVI en esta población con determinadas infecciones graves y caracterizar la relación entre la FC y la respuesta clínica y microbiológica a CAZ-AVI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.>18 years of age inclusive
    2.Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 28 days after last infusion
    3.Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, the study-qualifying culture), which was determined to be the causative agent of the entry infection
    4.Patients who have received appropriate prior empiric antibacterial therapy for a ceftazidime resistant pathogen prior to study entry
    1. El paciente debe tener una edad > 18 años.
    2. Las mujeres están autorizadas a participar en este estudio clínico si han sido esterilizadas quirúrgicamente o han completado la menopausia ó estando en edad fértil están dispuestas a no quedarse embarazadas durante el tratamiento y durante al menos 28 días después de la última infusión del tratamiento del estudio
    3. El paciente tiene un patógeno gram negativo resistente a la ceftazidima que se aisló de un cultivo adecuado en los 5 días previos a la entrada en el estudio (es decir, el cultivo requerido para el estudio), el cual se determinó que era el agente causante de la infección de entrada
    4. Los pacientes que hayan recibido previamente tratamiento antibacteriano empírico adecuado para un patógeno resistente a la ceftazidima
    E.4Principal exclusion criteria
    1.Patient has an APACHE II score >30
    2.Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.)
    3.Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
    4.Patient is immunocompromised
    5.Patient has a rapidly progressive or terminal illness, including acute hepatic failure or respiratory failure with a high risk of mortality due to other causes
    1. El paciente tiene una puntuación APACHE II >30
    2. El paciente presenta una infección por una especie bacteriana gram negativa con pocas probabilidades de responder al tratamiento con CAZ-AVI (por ejemplo, especies de Acinetobacter, especies de Stenotrophomonas)
    3. El paciente está recibiendo hemodiálisis o diálisis peritoneal ó tenga un trasplante renal
    4. Pacientes con inmunodepresión
    5. El paciente tiene una enfermedad terminal o rápidamente progresiva, incluida insuficiencia hepática aguda o insuficiencia respiratoria con un alto riesgo de mortalidad debida a otras causas
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with clinical cure at the Treatment of Cure visit.
    La proporción de pacientes con curación clínica en la visita Comprobación de la curación.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7-10 days after last infusion
    7-10 días después de la última infusión
    E.5.2Secondary end point(s)
    - Proportion of patients with clinical cure at the EOT, FU1, and FU2 visits in the MITT analysis set and at the EOT, TOC, FU1, and FU2 visits in the extended microbiologically evaluable (ME) analysis set
    - Proportion of patients with clinical cure at the TOC visit, by pathogen (eg, E. coli, Klebsiella spp., Pseudomonas aeruginosa) and by entry diagnosis (cIAI/cUTI), in the MITT and extended ME analysis sets
    - Proportion of patients with clinical cure by previously failed treatment class (eg, quinolone, beta lactam/beta lactamase inhibitor, third- or fourth generation cephalosporin, carbapenem), at the TOC visit in the MITT analysis set, and at the EOT, TOC, FU1, and FU2 visits in the extended ME analysis set
    - Proportion of favorable per-pathogen microbiological response at the EOT, TOC, FU1, and FU2 visits in the MITT and extended ME analysis sets
    - Proportion of patients with a favorable per-patient microbiological response at the EOT, TOC, FU1, and FU2 visits in the MITT and extended ME analysis sets
    - Proportion of patients with a favorable microbiological response at the TOC visit by resistance mechanism (eg, Klebsiella pneumoniae carbapenemase producer, extended-spectrum beta lactamase producer) in the MITT and extended ME analysis sets
    - Proportion of favorable per-pathogen microbiological response at the EOT, TOC, FU1, and FU2 visits, by minimum inhibitory concentration (MIC) categories in the MITT and extended ME analysis sets
    - Reasons for treatment change and/or discontinuation in the MITT analysis set
    - The 28-day mortality rate in the MITT and extended ME analysis sets
    - Proporción de pacientes con curación clínica en las visitas FDT, SEG1 y SEG2 en el grupo de análisis ITM y en las visitas FDT, CDC, SEG1 y SEG2 en el grupo de análisis evaluable microbiológicamente (EM) ampliado
    - Proporción de pacientes con curación clínica en la visita CDC, por patógeno (p. ej., E. coli, género Klebsiella, Pseudomonas aeruginosa), por mecanismo de resistencia (p. ej., cepas productoras de carbapenemasa de Klebsiella pneumoniae [KPC], cepas productoras de betalactamasa de espectro ampliado [BLEA]) y por diagnóstico de inclusión (IIAc/IUc), en los grupos de análisis ITM y EM ampliado
    - Proporción de pacientes con curación clínica por grupo terapéutico con fracaso previo (por ejemplo, quinolona, betalactámico/inhibidor de betalactamasas, cefalosporina de la tercera o la cuarta generación, carbapenem), en la visita CDC en el grupo de análisis ITM, y en las visitas FDT, CDC, SEG1 y SEG2 en el grupo de análisis EM ampliado
    - Proporción de pacientes con una respuesta microbiológica favorable por patógeno en las visitas FDT, CDC, SEG1 y SEG2 en los grupos de análisis ITM y EM ampliado
    - Proporción de pacientes con una respuesta microbiológica favorable por paciente en las visitas FDT, CDC, SEG1 y SEG2 en los grupos de análisis ITM y EM ampliado
    - Proporción de pacientes con una respuesta microbiológica favorable en la visita CDC por mecanismo de resistencia (por ejemplo, cepa productora de KPC, cepa productora de BLEA) en los grupos de análisis ITM y EM ampliado
    - Proporción de pacientes con una respuesta microbiológica favorable por patógeno en las visitas FDT, CDC, SEG1 y SEG2, por categoría de concentración inhibidora mínima (CIM), en los grupos de análisis ITM y EM ampliado
    - Motivos de la modificación o la interrupción del tratamiento en el grupo de análisis ITM
    - Tasa de mortalidad a los 28 días en los grupos de análisis ITM y EM ampliado
    E.5.2.1Timepoint(s) of evaluation of this end point
    The results of the RP study will be analyzed at 3 or more different timepoints including (a) in a timeframe to allow the submission of this RP data with the pivotal phase III cIAI and cUTI data in the regulatory submissions, (25-Jan-13) (b) in a timeframe to allow the latest RP data to be included in breakpoint discussions, (TBD) and (c) at the end of the RP study (Stat report/TLFs 23-Dec-14 and final CSR 22-Apr-15)
    Los resultados de este estudio se analizarán en 3 o más momentos diferentes, a saber: (a) en un plazo que permita la presentación de estos datos sobre patógenos resistentes junto con los datos de los estudios fundamentales en fase III sobre IIAc y IUc en solicitudes de autorización (25-Ene-13), (b) en un plazo que permita la inclusión de los datos más recientes sobre patógenos resistentes en las discusiones sobre los límites de sensibilidad (TBD), y (c) al final de este estudio (Informe estadístico/TLFs 23-Dic-14 y CSR final 22-Abr-15).
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers and Microbiology cultures
    Biomarcadores y cultivos microbiológicos
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Argentina
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Croatia
    Czech Republic
    France
    Germany
    Greece
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Taiwan
    Turkey
    Ukraine
    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
    The end of the study is defined as the last visit of the last patient participating in the study.
    El final del estudio se define como la última visita del último paciente participante en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 256
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 144
    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
    patients may be intubated and/or sedated and therefore not capable of providing consent
    Pacientes han de estar intubados y/ó sedados y por lo tanto no son capaces de dar el consentimiento
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 400
    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)
    Standard of care
    normas asistenciales
    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 Decision2012-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-20
    P. End of Trial
    P.End of Trial StatusCompleted
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