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    Summary
    EudraCT Number:2018-000775-32
    Sponsor's Protocol Code Number:AB.OH.2018
    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:2018-04-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-000775-32
    A.3Full title of the trial
    Phase IV, randomized, open, parallel groups clinical trial for evaluating the early Stop of antibiotic Treatment in febrile neutropenic Oncohematological Paediatric patients.
    Estudio de fase IV, aleatorizado, abierto de grupos paralelos para evaluar la finalización de tratamiento antibiótico en pacientes pediátricos oncohematológicos con neutropenia febril
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IV, randomized, open, parallel groups clinical trial for evaluating the early Stop of antibiotic Treatment in febrile neutropenic Oncohematological Paediatric patients.
    Estudio de fase IV, aleatorizado, abierto de grupos paralelos para evaluar la finalización de tratamiento antibiótico en pacientes pediátricos oncohematológicos con neutropenia febril
    A.3.2Name or abbreviated title of the trial where available
    eSTOP-study
    eSTOP-study
    A.4.1Sponsor's protocol code numberAB.OH.2018
    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 SponsorVall d'Hebron Institut de Recerca
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVall d'Hebron Institut de Recerca
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVall d'Hebron Institut de Recerca
    B.5.2Functional name of contact pointPere Soler
    B.5.3 Address:
    B.5.3.1Street AddressPg. Vall d'Hebron 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number34934893000
    B.5.6E-mailpsoler@vhebron.net
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namepiperacillin tazobactam
    D.3.4Pharmaceutical form Powder and solvent 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 INNPIPERACILLIN
    D.3.9.3Other descriptive namePIPERACILLIN
    D.3.9.4EV Substance CodeSUB09867MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTAZOBACTAM
    D.3.9.3Other descriptive nameTAZOBACTAM
    D.3.9.4EV Substance CodeSUB10849MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number12.5
    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 amikacin
    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 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 INNAMIKACIN
    D.3.9.1CAS number 37517-28-5
    D.3.9.4EV Substance CodeSUB05431MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 22.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Meropenem
    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 concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEROPENEM
    D.3.9.1CAS number 96036-03-2
    D.3.9.3Other descriptive nameMEROPENEM
    D.3.9.4EV Substance CodeSUB08778MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cefepime
    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 infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEFEPIME
    D.3.9.1CAS number 88040-23-7
    D.3.9.4EV Substance CodeSUB07390MIG
    D.3.10 Strength
    D.3.10.1Concentration unit millilitre(s)/kilogram
    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: 5
    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 Vancomycin
    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 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 INNVANCOMYCIN
    D.3.9.1CAS number 1404-90-6
    D.3.9.4EV Substance CodeSUB05076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Febrile neutrophenia in oncohematological pediatric patients.
    Pacientes oncohematológicos pediátricos con neutropenia febril
    E.1.1.1Medical condition in easily understood language
    Febrile neutrophenia in oncohematological pediatric patients.
    Pacientes oncohematológicos pediátricos con neutropenia febril
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10016288
    E.1.2Term Febrile neutropenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    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 safety of antibiotic withholding in pediatric cancer patients with FN with negative bacterial cultures at 48-72 hours after the onset of fever, absence of demonstrated bacterial infection, good clinical evolution (fever resolution and clinical stability) and PCT < 0,5ng/ml (experimental group), compared to classical strategy (control group), with regards to adverse events attributed to infection (death, PICU admission, sepsis, microbiology defined infection, radiologically confirmed pneumonia).
    Evaluar la seguridad de la retirada precoz de antibióticos en el paciente pediátrico hematoncológico con neutropenia febril (< 500 neutrófilos/mm3) con ausencia de infección bacteriana demostrada, buena evolución clínica y valores bajos de biomarcadores (PCR < 5 mg/dl, PCT <0,5 ng/ml) (grupo experimental), comparado con la estrategia clásica (grupo control) en lo que respecta a acontecimientos adversos atribuibles a infección bacteriana (muerte, ingreso en UCIP, sepsis, infección definida clínica y/o microbiológicamente, neumonía confirmada radiológicamente).
    E.2.2Secondary objectives of the trial
    1. To evaluate efficacy of antibiotic withholding as described previously, with regards to days of fever and total days of antibiotics.
    2. To evaluate days of antibiotic reduction in the experimental group.
    3. To evaluate reduction of adverse effects of prolonged antibiotic therapy in the experimental group.
    4. To retrospectively evaluate the utility of biomarkers to better predict invasive bacterial infection at the fever onset and 48-72 hours after.
    5. To validate a risk stratification score in our population.
    1. Evaluar la eficacia de la intervención del estudio, en lo que respecta a días de fiebre y total de días de antibiótico.
    2. Evaluar la reducción de días de antibiótico en el grupo experimental.
    3. Evaluar la reducción de efectos adversos de antibioterapia prolongada en el grupo experimental.
    4. Evaluar la utilidad de los biomarcadores para predecir mejor la infección bacteriana invasiva al ingreso y a las 48-72 horas del inicio de la fiebre.
    5. Validar un sistema de estratificación de riesgo adaptado a nuestro centro para esta población.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Female and male outpatients ≤18 years with haematological or solid malignancies.
    - Admission due to FN (defined as an axillary temperature >38.3°C or two consecutive readings of >38.0°C for 1 hour and an absolute neutrophil count <0.5 neutrophils/mm3, or expected to fall below 0.5 neutrophils/mm3 during the next 48 hours).
    - Antibiotic treatment initiated in the current FN episode (prior standard antimicrobial prophylaxis will be accepted).
    - Low risk of invasive bacterial infection at admission:
    o None of the following: serum level of CRP ≥ 9 mg/dl, hypotension, relapse of leukemia as type of cancer, platelet count ≤50,000 platelets/mm3, initiation of fever less than 7 days from last chemotherapy). Platelet count ≤50,000 platelets/mm3 or initiation of fever less than 7 days from the last chemotherapy alone will be accepted.
    - Absence of a demonstrated bacterial infection at 48h-72 hours after admission (positive culture from a sterile site, clinically diagnosed infection or radiologically confirmed pneumonia).
    - Good clinical evolution at 48-72 hours after admission (afebrile >24h (temperature ≤38ºC), haemodinamic stability, stable pediatric assessment triangle).
    - CRP ≤ 5 mg/dl and PCT ≤ 0.5 ng/dl at 48-72 hours after admission.
    - ANC < 0.5 neutrophils/mm3 at 48-72 hours after admission.
    - Patient/parent(s)/legal representative(s) must possess writing and reading abilities sufficient to comprehend the study.
    - Patient/parent(s)/legal representative(s) is considered reliable and capable of adhering to the protocol.
    - Pacientes de sexo femenino y masculino ≤18 años afectos de neoplasias hematológicas o sólidas.
    - Neutropenia febril (NF) como diagnóstico principal al ingreso, definida como una única medición de temperatura axilar >38.3°C o dos mediciones separadas por una hora >38.0°C en un paciente con un recuento absoluto de neutrófilos < 500 neutrófilos/mm3, o que se espera que desciendan por debajo de ese valor durante las próximas 48 horas.
    - Tratamiento antibiótico iniciado en el episodio actual de NF (se aceptarán las profilaxis antimicrobianas habituales).
    - Bajo riesgo de infección bacteriana invasiva al ingreso:
    o Ninguno de los siguientes: PCR ≥ 9 mg/dl, hipotensión, recaída de leucemia como enfermedad de base, recuento plaquetar ≤50,000 plaquetas/mm3, inicio de fiebre menos de 7 días tras la última quimioterapia. Se aceptará la presencia aislada de recuento plaquetar ≤50,000 platequetas/mm3 o inicio de la fiebre menos de 7 días tras la última quimioterapia.
    - Ausencia de infección bacteriana demostrada a las 48-72 horas del ingreso, definida como cultivo bacteriano positivo, infección diagnosticada clínicamente o neumonía confirmada radiológicamente.
    - Buena evolución clínica a las 48-72 horas del ingreso, definida como afebril >24h (temperatura axilar <38ºC), estable hemodinámicamente y con un triángulo de evaluación pediátrica estable.
    - PCR ≤ 5 mg/dl y PCT <0,5 ng/dl a las 48-72 horas del ingreso.
    - ANC < 500 neutrófilos/mm3 a las 48-72 horas del ingreso.
    - El paciente/padre(s)/representante(s) legal(es) deberán poseer habilidades de lectura y escritura suficientes para entender y dar su conformidad para participar en el estudio.
    - El paciente/padre(s)/representante(s) legal(es) deberán considerarse fiables y capaces de adherirse al protocolo.
    E.4Principal exclusion criteria
    - Patient that has undergone stem cell transplantation
    - Patient with acute myeloblastic leukemia or Philadelphia-positive acute lymphoblastic leukemia
    - Admission due to other cause different from FN.
    - Antibiotic treatment prior to admission other than the usual antimicrobial prophylaxis.
    - Empiric antibiotic therapy not in accordance with internal protocol.
    - Confirmed allergy to betalactams.
    - Bad clinical evolution in the first 12 hours after admission (haemodinamic instability, admission to PICU, death).
    - Actively participating in the study at the beginning of the current FN episode.
    - Concurrent participation in any other clinical trial.
    - Any condition for which, in opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit or confound the protocol-specified assessments.
    - Female subjects who are pregnant or breast-feeding
    - Signed informed consent by patient/parent(s)/legal representative(s).
    - Paciente sometido a trasplante de progenitores hematopoyéticos.
    - Paciente afecto de leucemia aguda mieloblástica o leucemia aguda linfoblástica Philadelphia positivo.
    - Ingreso por otro motivo diferente de neutropenia febril.
    - Tratamiento antibiótico en el momento del ingreso diferente al usado de forma profiláctica.
    - Tratamiento antibiótico empírico diferente al indicado en el protocolo interno.
    - Alergia confirmada a betalactámicos.
    - Paciente con mala evolución clínica en las primeras 12 horas (inestabilidad hemodinámica, ingreso en UCIP, muerte).
    - Participación activa en el mismo estudio al inicio del episodio actual de NF.
    - Participación activa en otro ensayo clínico.
    - Cualquier condición que, en opinión del investigador, cause que la participación en el estudio no sea adecuada para el paciente o que podría limitar, impedir o confundir las valoraciones previstas en el protocolo.
    - Mujeres embarazadas o en periodo de lactancia
    - Consentimiento informado firmado por el paciente/padre(s)/representante(s) legal(es).
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events attributed to infection (death, PICU admission, sepsis, microbiology and/or clinically defined infection, radiologically confirmed pneumonia).
    Acontecimientos adversos atribuibles a infección bacteriana: muerte, ingreso en UCIP, sepsis, infección definida clínica y/o microbiológicamente, neumonía confirmada radiológicamente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 días
    E.5.2Secondary end point(s)
    - Days of fever.
    - Days of and type of antimicrobials.
    - Days of neutropenia.
    - Patient characteristics: age, gender, origin, underlying disease, treatment phase, days from last chemotherapy, catheter type, clinical features, physical examination, hours of fever at admission, vital signs, PICU admission, risk score.
    - Analytical values (at admission, at 48-72 hours and at 28 days): hematology panel, serum chemistry panel (appendix), PCR, PCT.
    - IL-8 (at admission and at 48-72 hours).
    - Microbiological results: blood and urine cultures. Others if performed (nasopharyngeal swab, cerebrospinal fluid culture, etc).
    - Imaging results: X-ray, CT scan, MRI, US, others.
    - Incidence and severity of adverse effects.
    - Concomitant medication.
    - Días de fiebre.
    - Días y tipo de antibióticos administrados.
    - Días de neutropenia.
    - Características del paciente: edad, sexo, origen, enfermedad de base, fase de tratamiento, días desde el último ciclo de quimioterapia, tipo de catéter, signos y síntomas clínicos, examen físico, constantes vitales, horas de fiebre al ingreso, ingreso en UCIP, clasificación de riesgo.
    - Resultados analíticos (al ingreso, a las 48-72 horas y a los 28 días): hematología, bioquímica sérica (anexos), PCR, PCT,
    - Resultado de la determinación de IL-8 (al ingreso y a las 48-72 horas).
    - Resultados microbiológicos: hemocultivo, urocultivo, otros si se realizan (aspirado nasofaríngeo, cultivo de líquido cefalorraquídeo, etc.).
    - Pruebas de imagen: radiografía, ecografía, TC, otros.
    - Incidencia y gravedad de efectos adversos.
    - Medicación concomitante administrada.
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 and 72 hours
    7 and 14 days
    48 y 72 horas
    7 y 14 días
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Práctica Clínica Habitual
    Standar of Care
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee 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
    LVLS
    Última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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: 250
    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: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 120
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 120
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Pediatric patients
    Pacientes pediátricos
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    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 according to the site guidelines.
    Práctica clínica habitual según las guías clínicas del centro
    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 Decision2018-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-23
    P. End of Trial
    P.End of Trial StatusOngoing
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