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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2015-003274-32
    Sponsor's Protocol Code Number:2015/233
    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:2016-02-03
    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 number2015-003274-32
    A.3Full title of the trial
    Effect of caffeine citrate in acute bronchiolitis symptoms of apnea in neonates and infants during the first three months of life
    Efecto del citrato de cafeína en las bronquiolitis agudas con sintomatología de apnea en neonatos y lactantes durante los primeros tres meses de vida
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of caffeine citrate in acute bronchiolitis symptoms of apnea in neonates and infants during the first three months of life
    Efecto del citrato de cafeína en las bronquiolitis agudas con sintomatología de apnea en neonatos y lactantes durante los primeros tres meses de vida
    A.4.1Sponsor's protocol code number2015/233
    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 SponsorDra Maria Luz Couce
    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 supportChiesi Farmaceutici S.p.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrialance
    B.5.2Functional name of contact pointMercedes Villa
    B.5.3 Address:
    B.5.3.1Street AddressC/Molino 107 SA 2ª
    B.5.3.2Town/ cityEsplugues de LLobregat (Barcelona)
    B.5.3.3Post code08950
    B.5.3.4CountrySpain
    B.5.4Telephone number+34636262669
    B.5.6E-mailmvilla@trialance.com
    B.Sponsor: 2
    B.1.1Name of SponsorDr. José Luis Fernández Trisac
    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 supportCHIESI
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDra. Maria Luz Couce
    B.5.2Functional name of contact pointMaria Luz Couce
    B.5.3 Address:
    B.5.3.1Street AddressA Choupana
    B.5.3.2Town/ citySantiago de Compostela
    B.5.3.3Post code15706
    B.5.3.4CountrySpain
    B.5.4Telephone number+34981950151
    B.5.6E-mailMaria.Luz.Couce.Pico@sergas.es
    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 Peyona
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Farmaceutici, S.P.A
    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.3.11 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
    Children under 3 years with acute RSV bronchiolitis which present breaks apnea
    Niños menores de 3 años con bronquiolitis aguda por VRS que presentan pausas de apnea
    E.1.1.1Medical condition in easily understood language
    Children under 3 years with a respiratory infection caused by respiratory syncytial virus and having pauses in breathing
    Niños menores de 3 años con una infección respiratoria causada por el virus respiratorio sincitial y que presentan pausas en la respiración
    E.1.1.2Therapeutic area Not possible to specify
    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 determine whether treatment with caffeine improves clinically children under 3 months with acute bronchiolitis RSV having apnea pauses, decreasing the frequency and intensity of these
    Determinar si el tratamiento con cafeína mejora clínicamente a los niños menores de 3 meses con bronquiolitis aguda por VRS que presentan pausas de apnea, disminuyendo la frecuencia e intensidades de las mismas.
    E.2.2Secondary objectives of the trial
    Assess whether the number of days of hospitalization is reduced
    - Study of various clinical variables such as prematurity, birth weight, presence of comorbid conditions (heart disease, bronchopulmonary dysplasia ...)
    - Valorar si se reduce el nº de días de estancia hospitalaria
    - Estudio de diferentes variables clínicas como prematuridad, peso al nacimiento, presencia de alguna comorbilidad asociada (cardiopatía, displasia broncopulmonar...)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Neonatos Aged between 0 and 90 days days diagnosed with acute respiratory syncytial virus bronchiolitis who present clinical symptoms of apnea
    -Informed Consent participation in the study, signed by parents or legal guardians of the newborn
    -Neonatos con edad comprendida entre 0 y 90 días días diagnosticados de bronquiolitis aguda por virus respiratorio sincitial que presenten sintomatología clínica de apnea
    -Consentimiento informado de participación en el estudio, firmado por los padres o tutores legales del neonato
    E.4Principal exclusion criteria
    -Which the family does not accept the informed consent
    - Patients who are being treated with caffeine
    - Patients with severe kidney or liver failure.
    - Caffeine increases heart rate, left ventricular volume and stroke volume output. Consequently newborns with known cardiovascular disease are excluded from this study.
    -Patients with hypoglycemia and / or electrolyte imbalance
    -Patients treated for gastroesophageal reflux
    - History of seizures
    -Patients with severe birth defects of the respiratory tract (severe tracheomalacia, tracheoesophageal fistula, diaphragmatic hernia, congenital lobar emphysema, cystic adenomatoid malformation)
    -Que la familia no acepte el consentimiento informado
    -Pacientes que estén recibiendo tratamiento con cafeína
    - Pacientes con insuficiencia hepática o renal grave.
    - La cafeína incrementa la frecuencia cardiaca, el volumen de salida ventricular izquierdo y el volumen sistólico. Por consiguiente los recién nacidos con enfermedad cardiovascular conocida se excluyen de este estudio.
    -Pacientes con hipoglucemia y/o trastornos hidroelectrolíticos
    -Pacientes en tratamiento por reflujo gastroesofágico
    - Antecedentes de crisis convulsivas
    -Pacientes con anomalías congénitas severas del trato respiratorio (traqueomalacia severa, fístula traqueo-esofágica, hernia diafragmática, enfisema lobar congénito, malformación adenomatoidea quística)
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of at least 50% of apneas
    Reducción de al menos el 50% de apneas
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 5 days of treatment
    A los 5 días de tratamiento
    E.5.2Secondary end point(s)
    In both groups we will collect the following data:
    Birthdate
    Sex
    Birth weight
    Gestational age
    Age at entry
    Weight income
    Personal history (if it is basically healthy or has any underlying disease)
    Mother / father smoking
    Number of siblings and day care attendance
    Cohabiting with respiratory infection
    Type lactation: maternal, artificial or mixed
    If you received palivizumab prophylaxis
    Temperature
    Frequency of apneas / previous day at baseline, heart and respiratory rate, oxygen saturation, CO2 and signs of respiratory distress on admission and every 24 hours until discharge.

    - In the group treated with caffeine also we collect data:
    If we started treatment with caffeine citrate, date and dose
    Days of treatment with caffeine citrate
    Day admission that treatment began with caffeine citrate
    Other concomitant therapy: nebulized epinephrine, nebulized hypertonic saline, oxygen.
    Need for noninvasive mechanical ventilation (CPAP / BiPAP) and number of days
    Need for endotracheal intubation and mechanical ventilation and number of days.
    Need for nutritional support: gavage, parenteral nutrition.
    Stay in ICU / hospital
    Facts superinfection / need for antibiotics
    Other complications.

     In the untreated group caffeinated collect the same data except:
    If we started treatment with caffeine citrate doses
    Days of treatment with caffeine citrate
    Day admission that treatment began with caffeine citrate
    - En ambos grupos recogeremos los siguientes datos:
    o Fecha de nacimiento
    o Sexo
    o Peso al nacimiento
    o Edad gestacional
    o Edad al ingreso
    o Peso al ingreso
    o Antecedentes personales (si es básicamente sano o presenta alguna enfermedad de base)
    o Madre/padre fumador
    o Número de hermanos y asistencia a guardería
    o Convivientes con infección respiratoria
    o Tipo de lactancia: materna, artificial o mixta
    o Si recibió Profilaxis con Palivizumab
    o Temperatura
    o Frecuencia de apneas/día previo al inicio del tratamiento, frecuencia cardiaca y respiratoria, saturación de oxígeno, CO2 y presencia de signos de dificultad respiratoria al ingreso y cada 24 horas hasta el alta hospitalaria.
    - En el grupo de tratamiento con cafeína recogeremos además datos de :
    o Si se instauró tratamiento con citrato de cafeína, fecha y dosis
    o Días de tratamiento con citrato de cafeína
    o Día de ingreso en que se inició el tratamiento con citrato de cafeína
    o Otros tratamientos concomitantes: adrenalina nebulizada, suero salino hipertónico nebulizado, oxigenoterapia.
    o Necesidad de ventilación mecánica no invasiva (CPAP/BIPAP) y nº de días
    o Necesidad de intubación orotraqueal y ventilación mecánica y nº de días.
    o Necesidad de soporte nutricional: alimentación mediante sonda nasogástrica, nutrición parenteral.
    o Estancia en UCI/hospitalización
    o Datos de sobreinfección/necesidad de antibióticos
    o Otras complicaciones.
    En el grupo sin tratamiento con cafeína recogeremos los mismos datos excepto:
    o Si se instauró tratamiento con citrato de cafeína y dosis
    o Días de tratamiento con citrato de cafeína
    o Día de ingreso en que se inició el tratamiento con citrato de cafeína
    E.5.2.1Timepoint(s) of evaluation of this end point
    In Both groups we will collect the following data at hospital admission:
    Demographic / clinic / treatment group and dose / frequency of apneas / previous day at baseline, heart and respiratory rate, oxygen saturation, CO2 and signs of respiratory distress on admission and every 24 hours Until discharge data.
    During each visit:
    Days of caffeine citrate treatment / concomitant therapy: nebulized epinephrine, nebulized hypertonic saline, oxygen / Need for noninvasive mechanical ventilation (CPAP / BiPAP) and number of days / Need for endotracheal intubation and mechanical ventilation and number of days / Need for nutritional support : gavage, parenteral nutrition / Stay in ICU / hospital / superinfection Facts / need for antibiotics / Other complications.
    En ambos grupos al ingreso hospitalario:
    Grupo demográfico / clínica / tratamiento y dosis / frecuencia de apneas / día anterior al inicio del estudio, frecuencia cardiaca y respiratoria, saturación de oxígeno, CO2 y signos de dificultad respiratoria al ingreso y cada 24 horas hasta el alta.
    Durante cada visita:
    Días de tratamiento/ terapia concomitante: epinefrina nebulizada, solución salina hipertónica nebulizada, oxígeno / Necesidad de ventilación no invasiva mecánica (CPAP / BiPAP) y el número de días / Necesidad de intubación endotraqueal y la ventilación mecánica y el número de días / Necesidad de apoyo nutricional: alimentación forzada, la nutrición parenteral / Estancia en la UCI / Datos del hospital / superinfección / necesidad de antibióticos / Otras complicaciones.
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group 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 Yes
    E.8.2.3.1Comparator description
    tratamiento/no tratamiento
    Treatment/not treatment
    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 concerned2
    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
    The study period extends from the start of infection in autumn season until the end of the season infection in winter-spring 2017
    El periodo de estudio comprende desde el inicio de la temporada de infección en otño y hasta el fin de la temporada de infección en invierno-primavera de 2017
    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 months
    E.8.9.1In the Member State concerned days
    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: 105
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 50
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 55
    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
    The subjects are newborn and infants during the first three months of life
    Los sujetos reclutados son neonatos y lactantes durante los tres primeros meses de vida
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 96
    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)
    Patients wil be treated according the Standard of Care
    Los pacientes serán tratados de acuerdo a las prácticas clínicas habituales
    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 Decision2016-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-02
    P. End of Trial
    P.End of Trial StatusOngoing
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