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    Summary
    EudraCT Number:2014-003243-34
    Sponsor's Protocol Code Number:D3720C00009
    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:2015-01-12
    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 number2014-003243-34
    A.3Full title of the trial
    Open-label, Multicentre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline in Neonates and Young Infants with Late-Onset Sepsis
    Estudio abierto, multicéntrico, para evaluar la seguridad, tolerabilidad, farmacocinética y eficacia de ceftarolina en neonatos y en lactantes menores de 60 días con sepsis tardía
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, Tolerability and Efficacy of Ceftaroline in Babies with Late-Onset Sepsis
    Seguridad, tolerabilidad y eficacia de ceftarolina en bebés con sepsis tardía.
    A.4.1Sponsor's protocol code numberD3720C00009
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/074/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    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 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 pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus, Astraallén
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.4Telephone number0034900 811 335
    B.5.6E-mailClinicalTrialTransparency@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 Yes
    D.2.1.1.1Trade name Zinforo
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameceftaroline fosamil powder for concentrate for solution for infusion
    D.3.2Product code not applicable
    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 INNCeftaroline fosamil
    D.3.9.1CAS number 229016-73-3
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameZinforo
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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
    Late-onset Sepsis
    Sepsis tardía
    E.1.1.1Medical condition in easily understood language
    Sepsis
    Sepsis
    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 17.1
    E.1.2Level HLT
    E.1.2Classification code 10040054
    E.1.2Term Sepsis, bacteraemia, viraemia and fungaemia NEC
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of ceftaroline for the treatment of Late-onset sepsis in neonates and young infants aged 7 to <60 days
    Evaluar la seguridad y tolerabilidad de ceftarolina en el tratamiento de Sepsis Tardía en neonatos y lactantes de 7 días a <60 días de edad.
    E.2.2Secondary objectives of the trial
    - To evaluate the PK profile of ceftaroline in neonates and young infants aged 7 to <60 days with Late-onset sepsis
    - To evaluate the efficacy of ceftaroline for the treatment of Late-onset sepsis in neonates and young infants aged 7 to <60 days
    -Evaluar el perfil FC de ceftarolina en neonatos y lactantes de 7 días a <60 días de edad con Sepsis tardía.
    - Evaluar la eficacia de ceftarolina en el tratamiento de Sepsis tardía en neonatos y lactantes de 7 días a <60 días de edad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent in writing from parent(s) or other legally-acceptable representative(s)
    2. Male or female, gestational age >-34 weeks, and chronological age 7 to <60 days at the time of screening
    3. Diagnosis of sepsis within 36 hours before enrolment, defined as the presence of at least 2 clinical criteria and at least 2 laboratory criteria in the presence of or as a result of suspected or proven bacterial infection that requires IV antibiotic therapy.
    4. Patients must meet at least two of the following clinical criteria:
    (i) Hypothermia (<36°C) OR fever (>38.5°C)
    (ii) Bradycardia OR tachycardia OR rhythm instability
    (iii) Urine output 0.5 to 1 mL/kg/h OR hypotension OR mottled skin OR
    impaired peripheral perfusion
    (iv) Petechial rash OR sclerema neonatorum
    (v) New onset or worsening of apnoea episodes OR tachypnoea episodes OR
    increased oxygen requirements OR requirement for ventilation support
    (vi) Feeding intolerance OR poor sucking OR abdominal distension
    (vii) Irritability
    (viii) Lethargy
    (ix) Hypotonia.
    5. Patients must meet at least two of the following laboratory criteria:
    (i) White blood cell count <-4,000 × 109/L OR >-20,000 × 109/L
    (ii) Immature to total neutrophil ratio >0.2
    (iii) Platelet count <-100,000 × 109/L
    (iv) C-reactive protein (CRP) >15 mg/L OR procalcitonin >-2 ng/mL
    (v) Hyperglycaemia OR Hypoglycaemia
    (vi) Metabolic acidosis.
    1.Consentimiento informado por escrito del padre y/o la madre, o de otro(s) representante(es) legal(es).
    2. Niños o niñas, con edad gestacional >-34 semanas y edad cronológica de 7 días a <60 días en el momento de la selección.
    3. Diagnóstico de sepsis en las 36 horas previas a la inclusión, definida como la existencia de por lo menos 2 criterios clínicos y por lo menos 2 criterios de laboratorio en presencia de o como resultado de una infección bacteriana demostrada o de una sospecha de infección bacteriana que requiere tratamiento antibiótico i.v.
    4. Los pacientes deben cumplir como mínimo dos de los siguientes criterios clínicos:
    (i) Hipotermia (<36°C) O fiebre (>38,5°C)
    (ii) Bradicardia O taquicardia O inestabilidad del ritmo cardiaco
    (iii) Diuresis de 0,5 a 1 ml/kg/h O hipotensión O piel moteada O perfusión periférica deteriorada
    (iv) Exantema petequial O esclerema neonatal
    (v) Nueva presentación o empeoramiento de episodios de apnea O episodios de taquipnea O mayor necesidad de oxígeno O necesidad de soporte ventilatorio
    (vi) Intolerancia alimentaria O succión deficiente O distensión abdominal
    (vii) Irritabilidad
    (viii) Letargo
    (ix) Hipotonía
    5. Los pacientes deben cumplir como mínimo dos de los siguientes criterios de laboratorio:
    (i) Recuento de leucocitos <-4.000 × 109/l O >-20.000 × 109/l
    (ii) Proporción de neutrófilos inmaduros respecto al total de neutrófilos >0,2
    (iii) Recuento de plaquetas <-100.000 × 109/l
    (iv) Proteína C reactiva (PCR) >15 mg/l O procalcitonina >-2 ng/ml
    (v) Hiperglucemia O hipoglucemia
    (vi) Acidosis metabólica
    E.4Principal exclusion criteria
    1. Documented history of any hypersensitivity or allergic reaction to any beta-lactam antibiotic or aminoglycoside
    2. At study entry, has confirmed infection with a pathogen known to be resistant to the combination of ceftaroline fosamil, ampicillin, and the optional aminoglycoside of choice OR confirmed viral, fungal, or parasitic pathogen as the sole cause of infection
    3. Refractory septic shock within 24 hours before enrolment that does not resolve after 60 minutes of vasopressor therapy
    4. Moderate or severe renal impairment defined as serum creatinine >-2 times the upper limit of normal (× ULN) for age OR urine output <0.5 mL/kg/h (measured over at least 8 hours) OR requirement for dialysis
    5. Evidence of progressively fatal underlying disease, or life expectancy of <-60 days
    6. Documented history of seizure
    7. Requiring or currently taking antiretroviral therapy for human immunodeficiency virus (HIV) or a child from an HIV positive mother
    8. Proven or suspected central nervous system (CNS) infection (eg, meningitis, brain abscess, subdural abscess), osteomyelitis, endocarditis, or necrotizing enterocolitis (NEC)
    9. Any condition (eg, cystic fibrosis, urea cycle disorders), antepartum/peripartum factors, or procedures that would, in the opinion of the investigator, make the patient unsuitable for the study, place a patient at risk, or compromise the quality of data
    10. Patient's parent(s) or legally-acceptable representative(s) involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Concurrent participation in another clinical study with an investigational product (IP), previous enrolment/participation in this study, or participation in another study of ceftaroline fosamil within 14 days before the intended start of the first dose of study therapy.
    1. Antecedentes documentados de alguna reacción de hipersensibilidad o reacción alérgica a algún antibiótico betalactámico o aminoglucósido
    2. Infección confirmada en el momento de la inclusión en el estudio por un patógeno que se sabe que es resistente a la combinación de ceftarolina fosamil, ampicilina y el aminoglucósido de elección opcional O confirmación de que el único patógeno causante de la infección es un virus, hongo o parásito
    3. Shock séptico refractario en las 24 horas previas a la inclusión, que no se resuelve al cabo de 60 minutos de tratamiento vasopresor
    4. Insuficiencia renal moderada o grave, definida como un valor de creatinina sérica >-2 veces el límite superior de normalidad (× LSN) para la edad O diuresis <0,5 ml/kg/h (medida durante al menos 8 horas) O necesidad de diálisis
    5. Evidencia de enfermedad subyacente progresiva mortal, o expectativa de vida <- 60 días
    6. Antecedentes documentados de convulsiones
    7. Necesidad o toma actual de tratamiento antirretroviral para la infección por el virus de la inmunodeficiencia humana (VIH) o niño/a de una madre VIH positiva
    8. Infección demostrada o sospecha de infección del sistema nerviosos central (SNC) (por ej., meningitis, absceso cerebral, absceso subdural), osteomielitis, endocarditis o enterocolitis necrosante (ECN)
    9. Cualquier afección (por ej., fibrosis quística, trastornos del ciclo de la urea), factores prenatales/perinatales o procedimientos que, a criterio del investigador, hagan que el paciente no sea apto para participar en el estudio, pongan en riesgo al paciente o comprometan la calidad de los datos
    10. Implicación del padre y/o de la madre del paciente, o de su(s) representante(s) legal(es), en la planificación y/o ejecución del estudio (aplicable tanto al personal de AstraZeneca como al personal en el centro del estudio). Participación simultánea en otro estudio clínico con un producto en investigación (PI), inclusión/participación previa en el presente estudio o participación en otro estudio con ceftarolina fosamil en los 14 días anteriores a la fecha prevista de inicio de la administración de la primera dosis del tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The safety analysis will be performed on the Safety Analysis Set (all subjects who received drug) and will include AEs, SAEs, deaths, clinical laboratory parameters and vital signs.
    El analisis de seguridad se realizará en el cConjunto de Análisis de Seguridad ( todos los pacientes que hayan recibido fáramco) e incluiran AAs, AAGs, muertes, párametros clínicos de laboratorio y signos vitales.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Duration of study including safety follow up visit
    Duración del estudio inlcuyendo la visita de seguimiento de seguridad.
    E.5.2Secondary end point(s)
    1. Concentrations of ceftaroline fosamil, ceftaroline, and ceftaroline M-1 in plasma (and if available,
    concentrations of ceftaroline and ceftaroline M-1 in cerebrospinal fluid [CSF])
    2. Efficacy outcome measures will include clinical outcome at EOT and TOC in the Modified Intent-to- Treat (MITT) Analysis Set.
    1.Concentraciones de ceftarolina fosamil, ceftarolina y ceftarolina M-1 en plasma (y, si están disponibles, concentraciones de ceftarolina y ceftarolina M-1 en líquido cefalorraquídeo [LCR])
    2.Los criterios de valoración de la eficacia incluirán el resultado clínico en la visita de FDT y de PDC en el conjunto de análisis por intención de tratar modificada (ITM).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Treatment period at time of sampling
    2. End of Therapy vist and Test of Cure visit
    1. Período de tratamiento en el momento del muestreo.
    2.Visita de Fin de tratamiento y Visita de Test 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Hungary
    Italy
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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 Yes
    F.1.1Number of subjects for this age range: 8
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 8
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 8
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 8
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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
    Paediatrics
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 24
    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)
    After participation in the trial, if applicable, patients will be treated with the current standard therapy.
    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 Decision2015-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
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