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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-002203-18
    Sponsor's Protocol Code Number:P903-31
    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:2012-09-03
    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 number2012-002203-18
    A.3Full title of the trial
    A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone in Pediatric Subjects With Community-acquired Bacterial Pneumonia Requiring Hospitalization
    Estudio multicéntrico, aleatorizado, ciego para el
    observador, controlado con comparador activo, para evaluar la seguridad, tolerabilidad, farmacocinética y eficacia de ceftarolina frente a ceftriaxona en pacientes pediátricos con neumonía bacteriana adquirida en la comunidad que requieren hospitalización
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Blind (treatment to be received is not known), Controlled (a chance to receive any of the treatments to be given) Study to Assess How Safe and Acceptable Ceftaroline and Ceftriaxone are and Whether both can be Used to Treat Young Children Who have Pneumonia and Need to be Hospitalized.
    Estudio ciego (el tratamiento a recibir no se conoce), controlado (con posibilidad de recibir cualquiera de los tratamientos que se contenplan) para evaluar la seguridad y aceptabilidad de la ceftarolina ceftriaxona y si ambas se pueden utilizar para tratar a niños pequeños que tienen neumonía y necesitan ser hospitalizados.
    A.4.1Sponsor's protocol code numberP903-31
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/072/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCerexa, Inc. (subsidary of Forest Laboratories)
    B.1.3.4CountryUnited States
    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 supportCerexa, Inc. (subsidary of Forest Laboratories)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCerexa, Inc. (subsidary of Forest Laboratories)
    B.5.2Functional name of contact pointExecutive Director, Reg Affairs
    B.5.3 Address:
    B.5.3.1Street Address2100 Franklin St Suite 900
    B.5.3.2Town/ cityOakland
    B.5.3.3Post codeCA 94612
    B.5.3.4CountryUnited States
    B.5.4Telephone number0015102859228
    B.5.5Fax number001510859482
    B.5.6E-mailkhaeckl@cerexa.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 nameCeftaroline fosamil
    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.3.9.3Other descriptive namePPI-0903, TAK-599, ceftaroline acetate
    D.3.9.4EV Substance CodeSUB31648
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 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 nameCeftaroline fosamil
    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.3.9.3Other descriptive namePPI-0903, TAK-599, ceftaroline acetate
    D.3.9.4EV Substance CodeSUB31648
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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.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.2.1.1.1Trade name Ceftriaxone
    D.2.1.1.2Name of the Marketing Authorisation holderCristers
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 or 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 INNCeftriaxone Sodium
    D.3.9.1CAS number 74578-69-1
    D.3.9.3Other descriptive nameCEFTRIAXONE SODIUM
    D.3.9.4EV Substance CodeSUB01138MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    Community-acquired Bacterial Pneumonia
    Neumonía bacteriana adquirida en la Comunidad
    E.1.1.1Medical condition in easily understood language
    Pneumonia
    Neumonía
    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 15.0
    E.1.2Level PT
    E.1.2Classification code 10035664
    E.1.2Term Pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10004051
    E.1.2Term Bacterial pneumonia, unspecified
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10060946
    E.1.2Term Pneumonia bacterial
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10010120
    E.1.2Term Community acquired pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to < 18 years with CABP requiring hospitalization.
    Evaluar la seguridad y la tolerabilidad de la ceftarolina, en comparación con la ceftriaxona, en una población pediátrica de edades comprendidas entre los 2 meses y < 18 años con neumonía bacteriana
    adquirida en la comunidad (NBAC) que requiere hospitalización.
    E.2.2Secondary objectives of the trial
    ? Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects with CABP requiring hospitalization.

    ? Evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to < 18 years with CABP requiring hospitalization.
    ? Evaluar la eficacia de la ceftarolina, en comparación con la ceftriaxona, en sujetos pediátricos con NBAC que requieren hospitalización.
    ? Evaluar la farmacocinética de la ceftarolina en sujetos pediátricos de entre 2 meses y < 18 años de edad con NBAC que requieren hospitalización.
    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) and informed assent from subject (if age appropriate according to local requirements).
    2. Male or female 2 months to < 18 years of age.
    3. Presence of CABP warranting 3 days of initial hospitalization and a minimum of 3 days of IV antibacterial therapy and a minimum of 5 days but no more than 14 days total of study therapy (IV and PO combined).
    4. Presence of CABP meeting each of the following criteria:
    I. Fever (temperature > 38.0°C) or hypothermia (temperature <35.0°C). Note that temperature should not be measured by the axillary method.
    II. New infiltrate(s) compatible with bacterial pneumonia, including a new alveolar/lobar infiltrate or consolidation (based on imaging results or diagnostic testing)
    III. Acute onset or worsening within the previous 5 days before randomization of at least 2 of the following clinical signs or symptoms:
    - Cough
    - Tachypnea, defined as (World Health Organization, 2011):
    - 2 months to < 12 months: ? 50 breaths/min
    - 12 months to < 5 years: ? 40 breaths/min
    - ? 5 years: ? 20 breaths/min
    - Dyspnea
    - Grunting
    - Sputum production
    - Chest pain
    - Cyanosis
    - Evidence of pneumonia with parenchymal consolidation (eg, dullness on percussion, diminished breath sounds, egophony, bronchial breath sounds, rales or crackles)
    - Increased work of breathing (eg, nasal flaring, chest wall retractions)
    IV. Presence of at least 1 of the following:
    - Organism consistent with a typical respiratory pathogen identified or isolated from a respiratory or blood culture
    - Leukocytosis (> 15,000 white blood cells [WBC]/mm3)
    - >15% immature neutrophils (bands) regardless of total peripheral WBC
    - Leukopenia (< 4500 WBC/mm3) likely due to the bacterial infection
    - Hypoxemia (oxygen saturation < 92% on room air)
    5. Female subjects who have reached menarche must have a negative urine pregnancy test.
    6. Female subjects who have reached menarche and are sexually active must be willing to practice sexual abstinence or dual methods of birth control (eg, condom or diaphragm with spermicidal foam or gel) during treatment and for at least 28 days after the last dose of any study drug (IV or PO).
    7. Sufficient IV access to receive medication.
    1. Firma del documento de consentimiento informado por el padre, la madre o el representante legal y otorgamiento del consentimiento propio (si procede según la edad y la legislación del territorio).
    2. Sexo masculino o femenino y edad comprendida entre los 2 meses y los < 18 años.
    3. Diagnóstico de NBAC que requiera 3 días de hospitalización, un mínimo de 3 días de tratamiento antibacteriano i.v. y en total un mínimo de 5 días (pero no más de 14) de tratamiento del estudio (intravenoso y oral).
    4. Presencia de NBAC con todos los criterios siguientes:
    I. Fiebre (temperatura > 38,0 ºC) o hipotermia (temperatura < 35,0 ºC). Téngase en cuenta que la
    temperatura no debe medirse en la axila.
    II. Infiltrados nuevos compatibles con una neumonía bacteriana: nueva infiltración alveolar o lobular
    o consolidación (según el diagnóstico por la imagen o los estudios complementarios).
    III. Aparición aguda o empeoramiento, en los 5 días anteriores a la aleatorización, de al menos 2 de los siguientes signos o síntomas clínicos:
    ? Tos
    ? Taquipnea, definida (Organización Mundial de la Salud, 2011) como: o entre 2 meses y < 12 meses: ? 50 respiraciones por minuto; o entre 12 meses y < 5 años: ? 40 respiraciones por minuto; o ? 5 años: ? 20 respiraciones por minuto;
    ? Disnea
    ? Estridores o cornaje
    ? Expectoración
    ? Dolor torácico
    ? Cianosis
    ? Signos de neumonía con consolidación parenquimatosa (ej., matidez a la percusión, reducción de
    los ruidos respiratorios, egofonía, soplos tubáricos, estertores o crepitantes).
    ? Incremento del esfuerzo respiratorio (ej., aleteo nasal, tiraje).
    IV. Presencia de al menos una de las siguientes alteraciones:
    ? Identificación o aislamiento de un microorganismo compatible con un patógeno respiratorio típico a partir de un cultivo de sangre o esputo.
    ? Leucocitosis (> 15.000 unidades/mm3).
    ? Porcentaje de neutrófilos inmaduros (cayados) > 15%, con independencia del total de leucocitos en periferia.
    ? Leucocitopenia (< 4500 unidades/mm3) entendida como asociada a la bacteriosis.
    ? Hipoxemia (saturación de oxígeno < 92% en aire ambiente).
    5. En el caso de las chicas que hayan pasado la menarquia, negativo en la prueba del embarazo en orina.
    6. En el caso de las chicas que hayan pasado la menarquia y ya tengan relaciones sexuales, compromiso de abstenerse de mantener relaciones o de utilizar dos anticonceptivos simultáneamente (ej.,
    preservativo o diafragma junto con espuma o gel espermicida) durante el tratamiento y hasta que hayan transcurrido 28 días de la última dosis (intravenosa u oral).
    7. Acceso i.v. suficiente para poder recibir la medicación.
    E.4Principal exclusion criteria
    1. Documented history of any hypersensitivity or allergic reaction to any ?-lactam antimicrobial.
    2. Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone (eg, Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus [MRSA]) or known infection at baseline with a sole atypical organism (eg, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Chlamydia trachomatis, Legionella pneumophila). Epidemiological clues to potential MRSA infection include necrotizing pneumonia, existence of an ongoing local MRSA infection outbreak, known skin colonization with MRSA, recent invasive MRSA infection, and recent influenza. Subjects with risk factors for MRSA infection who have predominance of gram-positive cocci in clusters on sputum Gram stain should also be excluded.
    3. Confirmed or suspected respiratory tract infection attributable to sources other than community-acquired bacterial pathogens (eg, ventilator-associated pneumonia; hospital-acquired pneumonia [occurring 48 hours or more after admission, which was not incubating at the time of admission (Niederman, 1996; Tablan et al, 2004)]; visible/gross aspiration pneumonia; suspected sole viral [eg, respiratory syncytial virus], fungal, Mycobacterium tuberculosis infection of the lung); chronic lung disease or neurologic disease preventing normal clearance of secretions.
    4. Non-infectious causes of pulmonary infiltrates (eg, cystic fibrosis, chemical pneumonitis from aspiration, hypersensitivity pneumonia) on chest radiography.
    5. More than 24 hours of any potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization.
    EXCEPTIONS:
    a) Microbiological or clinical treatment failure with a nonstudy antibacterial therapy that was administered for at least 72 hours. Failure must be confirmed by either a microbiological laboratory report or documented worsening clinical signs or symptoms.
    b) Low-dose tetracycline derivative for acne (eg, doxycycline 50 mg q12h)
    6. Requirement for any potentially effective concomitant systemic antibacterial therapy
    7. Requirement for high-dose (eg, equivalent to > 20 mg of prednisone per day) or prolonged (ie, >14 days) systemic corticosteroid therapy; short courses of corticosteroids, such as those for currently worsening asthma, are permitted.
    8. History of seizures, excluding febrile seizure of childhood.
    9. Creatinine clearance < 50 mL/min/1.73 m2 as calculated using the updated Schwartz ?bedside? formula (Schwartz et al, 2009):
    CrCl (mL/min/1.73 m2) = 0.413 × height (length) (cm)/serum creatinine (mg/dL).
    10. Clinical signs or suspicion of bacterial meningitis.
    11. Evidence of significant hepatic, hematologic, or immunocompromising condition (any of the following):
    - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (× ULN) or total bilirubin level > 2 × ULN
    - Known acute viral hepatitis
    - Neutropenia (< 500 neutrophils/mm3)
    - Thrombocytopenia (< 60,000 platelets/mm3)
    - If human immunodeficiency virus (HIV)-positive, has CD4 count < 250 cells/mm3 at the last measurement or history of AIDS-defining illness
    - Bone marrow ablative therapy, including bone marrow transplantation, within the last 12 months
    - Bone marrow or solid organ recipients who have had an episode of graft versus host disease or acute rejection episode, respectively, within the last 6 months
    - Severe combined immunodeficiency disorder (SCID)
    12. Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less.
    13. Females who are currently pregnant or breastfeeding.
    14. Participation in any study involving administration of an investigational agent or device within 30 days before randomization or previously participated in the current study or in another study of ceftaroline fosamil (in which an active agent was taken or received).
    15. Unable or unwilling to adhere to the study-specified procedures and restrictions.
    16. Any condition (eg, septic shock, acute hemodynamic instability including those conditions requiring pressor support) that would make the subject, in the opinion of the Investigator, unsuitable for the study (eg, would place a subject at risk or compromise the quality of the data).
    1. Antecedentes documentados de hipersensibilidad o reacciones alérgicas a un antibiótico betalactámico.
    2. Confirmación o sospecha de infección por un patógeno de resistencia conocida a la ceftriaxona (ej., Pseudomonas aeruginosa, Staphylococcus aureus resistente a la meticilina [SARM]) o documentación de una monoinfección basal por un microorganismo atípico (Mycoplasma pneumoniae, Chlamydophila pneumoniae, Chlamydia trachomatis, Legionella pneumophila). Los indicios
    epidemiológicos indicativos de una posible infección por SARM son las neumonías necrosantes, la existencia de un brote de SARM en la población, la colonización cutánea documentada por SARM, los
    antecedentes recientes de infección invasiva por SARM y los antecedentes recientes de gripe. También
    quedarán excluidos los sujetos con factores de riesgo de infección por SARM que presenten un predominio de cocos grampositivos en racimos en la tinción de Gram del esputo.
    3. Documentación o sospecha de una infección de las vías respiratorias atribuible a una etiología distinta de las bacterias patógenas adquiridas en el ámbito extrahospitalario (ej., neumonía asociada a la ventilación mecánica, neumonía nosocomial [adquirida ? 48 horas después del ingreso y que no estuviese incubándose en el momento de ingresar (Niederman, 1996; Tablan y cols., 2004)], neumonía
    por aspiración visible/macroscópica, sospecha de infección monovírica [ej., virus sincicial respiratorio], micosis o infección pulmonar por Mycobacterium tuberculosis); neumopatía crónica o enfermedad neurológica que impida la eliminación normal de las secreciones.
    4. Etiología no infecciosa de los infiltrados pulmonares (ej., fibrosis quística, neumonitis química por aspiración, neumonía por hipersensibilidad) objetivados en la radiografía del tórax.
    5. Haber recibido, en las 96 horas anteriores a la aleatorización, más de 24 horas de una antibioticoterapia
    sistémica potencialmente efectiva contra la NBAC, con las excepciones siguientes:
    a) Fracaso microbiológico o clínico de una antibioticoterapia distinta de las del ensayo que se haya administrado ? 72 horas. El fracaso debe estar confirmado por un informe del laboratorio de microbiología o por la documentación del empeoramiento del cuadro clínico.
    b) Dosis bajas de un derivado tetraciclínico contra el acné (p. ej., doxiciclina 50 mg c/12 h).
    6. Necesidad de recibir de forma concomitante cualquier tipo de tratamiento antibacteriano sistémico que pueda resultar efectivo.
    7. Necesidad de recibir dosis elevadas (p. ej., equivalentes a > 20 mg de prednisona al día) o tratamiento prolongado (> 14 días) con un corticosteroide sistémico; se permiten no obstante los cursos cortos,
    p. ej. para una exacerbación del asma.
    8. Antecedentes de crisis convulsivas, a excepción de las convulsiones febriles en la infancia.
    9. Aclaramiento de creatinina (AcCr) < 50 ml/min/1,73 m2, calculado según la fórmula «de cabecera» de Schwartz actualizada (Schwartz y cols., 2009):
    AcCr (ml/min/1,73 m2) =
    0,413 × estatura (talla) (cm)/
    creatinina sérica (mg/dl)
    10. Signos clínicos o sospecha de meningitis bacteriana.
    11. Datos indicativos de la presencia de trastornos hepáticos, hematológicos o inmunitarios importantes
    (cualquiera de los siguientes):
    ? Concentración de aspartato-aminotransferasa (AST) o alanina-aminotransferasa (ALT) que supere
    > 3 veces el límite superior de la normalidad (× LSN) o bilirrubina total > 2 × LSN.
    ? Hepatitis vírica aguda documentada.
    ? Neutropenia (< 500 neutrófilos/mm3).
    ? Trombocitopenia (< 60.000 plaquetas/mm3).
    ? En caso de positivo del virus de la inmunodeficiencia humana (VIH), cifra de CD4
    < 250 células/mm3 en la última determinación, o antecedentes de enfermedades definitorias del
    sida.
    ? Tratamiento mieloablativo (incluido el trasplante de médula ósea) en los últimos 12 meses.
    ? En caso de ser receptor de médula ósea u órganos sólidos, episodio de enfermedad del injerto contra el huésped o de rechazo agudo, respectivamente, en los últimos 6 meses.
    ? Inmunodeficiencia combinada grave (IDCG).
    12. Indicios de enfermedad con riesgo de muerte inminente, enfermedad progresiva mortal o esperanza de vida ? 3 meses.
    13. En el caso de las chicas, embarazo o lactancia materna.
    14. Haber participado, en los 30 días anteriores a la aleatorización, en un estudio con un fármaco o un producto sanitario en investigación, o haber participado en este mismo ensayo o en otro del fosamilo
    de ceftarolina (en el cual el paciente haya recibido el producto activo).
    15. Incapacidad o falta de voluntad de someterse a las exploraciones del estudio y de respetar las restricciones impuestas.
    16. Cualquier trastorno (ej., shock septicémico, inestabilidad hemodinámica aguda o cuadros que requieran
    vasotensores) que, a juicio del investigador, contraindique la participación del sujeto (ej., porque comportaría un riesgo para su persona o porque pondría en entredicho la calidad de los datos).
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to < 18 years with CABP requiring hospitalization.
    El objetivo principal es evaluar la seguridad y la tolerabilidad de la ceftaolina versus la ceftriaxona en pacientes pediátricos de 2 meses de edad hasta < de 18 años con Neumonía bacteriana adquirida en la comunidad que requieren hospitalización.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ? Adverse events: AEs, SAEs, deaths, and discontinuations due to AEs will be evaluated. Cephalosporin class effects and additional AEs (including, but not limited to, seizures, Clostridium difficile-associated diarrhea, allergic reactions, hemolytic anemia, hepatic abnormalities, and changes in renal function) will be closely monitored at Treatment, EOIV, EOT, TOC, LFU.
    ? Clinical: vital signs (pulse, blood pressure, respiratory rate, oxygen saturation, and temperature) at Treatment, EOIV, EOT, TOC, LFU
    ? Laboratory: complete blood count with differential (at treatment day 7, EOIV, TOC), direct Coombs test (at TOC), and chemistry panel (at treatment day 2 and 3, EOIV)

    Refer to Schedule of Assessments and Procedures within the protocol
    ? Acontecimientos adversos: se documentarán los AA, los AAG, los fallecimientos y los casos de suspensión del tratamiento por causa de los AA. Se prestará especial atención a los efectos típicos de las cefalosporinas y a determinados AA (a título no limitativo: convulsiones, diarrea asociada a Clostridium difficile, reacciones alérgicas,
    anemia hemolítica, alteraciones hepáticas y alteraciones de la función renal) se seguirán de cerca ? Clínica: constantes vitales (pulso, tensión arterial, frecuencia respiratoria, saturación
    de oxígeno y temperatura) en el tratamiento, FTIV, FT, CC, VST.
    ? Laboratorio: hemogramas completos con fórmula leucocitaria (día 7 del tratamiento FTIV, CC), prueba directa de
    Coombs (CC) y bioquímica (días 2 y 3 del tratamiento, FTIV).
    E.5.2Secondary end point(s)
    1. Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects with CABP requiring hospitalization.
    2. Evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to < 18 years with CABP requiring hospitalization.
    1. Evaluar la seguridad y la tolerabilidad de la ceftaolina versus la ceftriaxona en pacientes pediátricos de 2 meses de edad hasta < de 18 años con Neumonía bacteriana adquirida en la comunidad que requieren hospitalización.
    2. Evaluar la farmacocinética de la ceftarolina en pacientes pediátricos de 2 meses de edad hasta < de 18 años con Neumonía bacteriana adquirida en la comunidad que requieren hospitalización.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ?Clinical response at Study Day4 by subject and by baseline pathogen in the Modified Intent-to-Treat and the Microbiological Modified Intent-to-Treat Populations
    ?Clinical stability at Study Day4 by subject and by baseline pathogen in the MITT and mMITT Populations
    ?Clinical outcome at End-of-Intravenous Study Drug, EOT, and TOC in the MITT and CE Populations
    ?Clinical and microbiological outcomes by subject and by baseline pathogen at TOC in the mMITT and Microbiologically Evaluable Populat.
    ?Clinical relapse at Late Follow-up in the MITT Population
    ?Emergent infections in the mMITT Population
    ?Concentrations of ceftaroline fosamil, ceftaroline, and ceftaroline M1 in plasma
    ?If available, concentrations of ceftaroline fosamil, ceftaroline, and ceftaroline M1 in cerebrospinal fluid
    ? Respuesta clín. por suj. y patóg. basal el día 4 en poblac. por intención de tratar modificada (ITM) y por intención de tratar modificada por microbiología (ITMm) ? Estab. clín. por suj. y patóg. basal el día 4 en poblac. ITM e ITMm? Evol. clín. al FTIV,al FT y en el mom. de la CC, en la poblac. ITM y con clín. evaluable (CE)? Evol. clín. y microbiol. por suj. y patóg. basal en el mom. de la CC, en la poblac. ITMm y con microbiol. evaluable (ME)? Recidiva clín. en la VST en la poblac. ITM. ? Infecciones aparecidas durante el tratam. en la poblac. ITMm? Concentraciones de ceftarolina,de fosamilo de ceftarolina (profármaco) y de ceftarolina M-1(metabolito inactivo) en el plasma ? Siempre q. haya muestras dispon.concentrac. de fosamilo,ceftarolina y ceftarolina M-1 en el líquido cefalorraq.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Observer Blinded
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Greece
    Hungary
    Poland
    Spain
    Ukraine
    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
    Last Subject Last Visit
    Último sujeto Última visita
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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 Yes
    F.1.1Number of subjects for this age range: 160
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 40
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 80
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    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 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
    Study to include children of age starting at 2 months until <18 years of age.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 160
    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
    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 Decision2013-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-14
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