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    Summary
    EudraCT Number:2012-004006-96
    Sponsor's Protocol Code Number:D4281C00001
    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:2013-01-11
    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 number2012-004006-96
    A.3Full title of the trial
    A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults
    Ensayo comparativo fase III, aleatorizado, multicéntrico, doble ciego, de doble simulación, de grupos paralelos, para determinar la eficacia, seguridad y tolerabilidad de Ceftazidima-Avibactam (CAZ-AVI) versus Meropenem en el tratamiento de la neumonía nosocomial (NN) incluyendo la neumonía asociada a ventilación mecánica (NAVM) en adultos hospitalizados.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing Ceftazidime-Avibactam versus Meropenem in hospitalized adults with nosocomial pneumonia
    Ensayo que compara Ceftazidima-Avibactam con Meropenem en el tratamiento de la neumonía nosocomial en adultos hospitalizados.
    A.4.1Sponsor's protocol code numberD4281C00001
    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 Center
    B.5.3 Address:
    B.5.3.1Street Address""
    B.5.3.2Town/ city""
    B.5.3.3Post code""
    B.5.3.4CountryUnited States
    B.5.4Telephone number""""""
    B.5.5Fax number""""""
    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 nameceftazidime 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 INNCEFTAZIDIME PENTAHYDRATE
    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 1192500-31-4
    D.3.9.4EV Substance CodeSUB72111
    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 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.2.1.1.1Trade name Meronem
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    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.3.4Pharmaceutical 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 INNMEROPENEM
    D.3.9.1CAS number 119478-56-7
    D.3.9.3Other descriptive nameMEROPENEM TRIHYDRATE
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/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
    nosocomial pneumonia (NP), ventilator-associated pneumonia (VAP)
    neumonía nosocomial (NN) incluyendo la neumonía asociada a ventilación mecánica (NAVM).
    E.1.1.1Medical condition in easily understood language
    lung infection
    Infección respiratoria
    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 assess the non-inferiority of ceftazidime-avibactam compared to meropenem with respect to clinical cure at the test of cure visit in patients in the clinically modified intent-to-treat population and patients in the clinically evaluable population
    Evaluar la no inferioridad de ceftazidima-avibactam en comparación con meropenem con respecto a la curación clínica en la visita de la prueba de curación en los pacientes de la población por intención de tratar clínicamente modificada y en los pacientes de la población clínicamente evaluable
    E.2.2Secondary objectives of the trial
    To determine the efficacy of CAZ-AVI compared to meropenem with respect to the clinical cure at end of treatment in the clinically modified intent-to-treat, clinically evaluable, microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable populations and at test of cure in the microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable populations
    To determine the efficacy of CAZ-AVI compared to meropenem with respect to the per patient microbiologic response and per-pathogen microbiologic response at the EOT and test of cure visits
    To evaluate the efficacy of CAZ-AVI and meropenem in patients with pathogens resistant to ceftazidime
    To estimate the all-cause mortality at test of cure and at Day 28
    To estimate the proportion of patients discharged from hospital up to the test of cure visit
    To evaluate the safety and tolerability
    To evaluate the pharmacokinetics
    Determinar la eficacia de CAZ AVI en comparación con meropenem con respecto a la curación clínica al final del tratamiento en las poblaciones con intención de tratar clinicamente modificada, clínicamente evaluable, por intención de tratar microbiológicamente modificada, microbiológicamente evaluable (ME), y ME extendida, y en la visita de la prueba de curación (TOC) en las poblaciones por de tratar microbiológicamente modificada, ME, y ME extendida
    Determinar la eficacia de CAZ AVI en comparación con meropenem con respecto a la respuesta microbiológica por paciente y la respuesta microbiológica por patógeno en las visitas EOT y TOC
    Evaluar la eficacia de CAZ AVI y meropenem en pacientes con patógenos resistentes a ceftazidima
    Calcular la mortalidad por todas las causas en la visita TOC y el día 28
    Estimar el porcentaje de pacientes que reciben el alta hospitalaria hasta la visita TOC
    Evaluar la seguridad y tolerabilidad
    Evaluar la farmacocinética
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    18 to 90 years of age inclusive
    Females can participate if surgically sterile or completed menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after
    Onset of symptoms ?48 hours after admission or <7 days after discharge from an inpatient acute or chronic care facility
    New or worsening infiltrate on chest X-ray obtained within 48 hours prior to randomization
    At least 1 of the following systemic signs:
    - Fever (temperature >38°C) or hypothermia (rectal/core temperature <35°C)
    - White blood cell count >10,000 cells/mm3, or White blood cell count <4500 cells/mm3, or >15% band forms
    Adultos de edad entre 18 y 90 años inclusive
    A las mujeres se les permite participar en este ensayo clínico si se han sometido a esterilización quirúrgica o son posmenopáusicas. Si son fértiles, deberán tener una prueba sérica de embarazo negativa, aceptar no intentar quedarse embarazada y usar métodos de anticoncepción válidos mientras recibe los fármacos del ensayo y durante un periodo de 1 semana después
    Inicio de los síntomas ?48 horas después del ingreso o <7 días después del alta de un paciente ingresado en una unidad de cuidados intensivos o en un centro para enfermos crónicos
    Nuevo infiltrado o empeoramiento de uno preexistente en una radiografía de tórax obtenida en las 48 horas previas a la aleatorización
    Al menos uno de los siguientes signos sistémicos:
    - Fiebre (temperatura >38ºC) o hipotermia (temperatura rectal/central<35ºC)
    - Recuento de leucocitos >10.000/mm3 o <4.500/mm3, o >15% de cayados
    E.4Principal exclusion criteria
    Pulmonary disease that precludes evaluation of therapeutic response (including, but not limited to, lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection or recent pulmonary embolism).
    Patients with lung abscess, pleural empyema or post obstructive pneumonia.
    Patients with an estimated creatinine clearance <16ml/min by Cockcroft Gault formula or patients expected to require haemodialysis or other renal support while on study therapy.
    Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decompensation of chronic hepatic failure.
    Patients receiving hemodialysis or peritoneal dialysis.
    Enfermedad pulmonar que impida evaluar la respuesta terapéutica (entre otras, cáncer de pulmón, tuberculosis activa, fibrosis quística, enfermedad granulomatosa, infección fúngica pulmonar o embolia pulmonar reciente).
    Pacientes con absceso pulmonar, empiema pleural o neumonía postobstructiva.
    Pacientes con un aclaramiento de creatinina estimado <16 ml/minuto mediante la fórmula de Cockcroft Gault o pacientes que se prevé que necesitarán hemodiálisis u otro soporte renal durante el tratamiento del ensayo.
    Hepatitis aguda en los 6 meses previos, cirrosis, insuficiencia hepática aguda o descompensación aguda de una insuficiencia hepática crónica.
    Pacientes en hemodiálisis o diálisis peritoneal.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with clinical cure in the clinically modified intent-to-treat and clinically evaluable analysis sets (co-primary analyses)
    Porcentaje de pacientes con curación clínica en los conjuntos de análisis de intención de tratar cínicamente modificada y clínicamente evaluables (análisis coprincipales).
    E.5.1.1Timepoint(s) of evaluation of this end point
    at test of cure visit
    en la visita de la prueba de curación
    E.5.2Secondary end point(s)
    The proportion of patients with clinical cure in the microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable analysis sets
    The proportion of patients with clinical cure in clinically modified intent-to-treat, clinically evaluable, microbiologically modified intent-to-treat, microbiologically evaluable, extended microbiologically evaluable analysis sets
    The proportion of patients with a favorable per-patient microbiologic response in microbiologically modified intent-to-treat, microbiologically evaluable, extended microbiologically evaluable analysis sets
    The proportion of favorable per-pathogen microbiologic responses in microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable analysis sets
    The proportion of favorable per-pathogen microbiologic responses by minimum inhibitory concentration categories in microbiologically modified intent-to-treat, microbiologically evaluable and extended-microbiologically evaluable analysis sets
    The proportion of patients with clinical cure in patients with pathogens resistant to ceftazidime in clinically evaluable, clinically modified intent-to-treat, microbiologically evaluable analysis sets
    Proportion of patients with a favorable per-patient microbiologic response in patients with pathogens resistant to ceftazidime in microbiologically modified intent-to-treat, microbiologically evaluable, extended microbiologically evaluable analysis sets
    The proportion of favorable per-pathogen microbiologic responses in patients with pathogens resistant to ceftazidime in microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable analysis sets
    The proportion of patients with death due to any cause (all-cause mortality) in the clinically evaluable, clinically modified intent-to-treat and microbiologically modified intent-to-treat analysis sets
    Porcentaje de pacientes con curación clínica en los conjuntos de análisis de intención de tratar microbiológicamente modificada, microbiológicamente evaluable (ME), y ME extendida
    Porcentaje de pacientes con curación clínica en los conjuntos de análisis de intención de tratar clínicamente modificada, clínicamente evaluable (CE), intención de tratar microbiológicamente modificada, ME y ME extendida
    Porcentaje de pacientes con una respuesta microbiológica por paciente favorable en los conjuntos de análisis intención de tratar microbiológicamente modificada, ME y ME extendida
    Porcentaje de respuestas microbiológicas favorables por patógeno en los conjuntos de análisis intención de tratar microbiológicamente modificada, ME y ME extendida
    Porcentaje de respuestas microbiológicas favorables por patógeno por categorías de concentración mínima inhibitoria en los conjuntos de análisis intención de tratar microbiológicamente modificada, ME y ME extendida
    Porcentaje de pacientes con curación clínica en pacientes con patógenos resistentes a ceftazidima en los conjuntos de análisis CE, intención de tratar clínicamente modificada, y ME
    Porcentaje de pacientes con una respuesta microbiológica por paciente favorable en pacientes con patógenos resistentes a ceftazidima en los conjuntos de análisis intención de tratar microbiológicamente modificada, ME y ME extendida
    Porcentaje de respuestas microbiológicas favorables por patógeno, en pacientes con patógenos resistentes a ceftazidima en los conjuntos de análisis intención de tratar microbiológicamente modificada, ME y ME extendida
    Porcentaje de pacientes con muerte debida a cualquier causa (mortalidad por todas las causas) en los conjuntos de análisis CE, intención de tratar clínicamente modificada e intención de tratar microbiológicamente modificada
    E.5.2.1Timepoint(s) of evaluation of this end point
    at end of treatment visit and test of cure visit
    en las visitas de final del tratamiento y de la prueba de curación
    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 Yes
    E.6.13.1Other scope of the trial description
    Microbiology cultures
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA81
    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
    Brazil
    Bulgaria
    Chile
    China
    Czech Republic
    France
    Hungary
    India
    Italy
    Japan
    Mexico
    Peru
    Poland
    Russian Federation
    Slovakia
    South Africa
    Spain
    Turkey
    Ukraine
    United Kingdom
    Vietnam
    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
    Last subject last visit
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days15
    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: 961
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 553
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients may require intubation with subsequent sedation and therefore not capable of providing consent.
    Pacientes con intubación con la sedación subsiguiente y por lo tanto incapacitados para proporcionar el consentimiento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 479
    F.4.2.2In the whole clinical trial 1494
    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
    Tratamiento habitual
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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