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    Summary
    EudraCT Number:2011-005741-13
    Sponsor's Protocol Code Number:PDA-pediatría
    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:2011-12-12
    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 number2011-005741-13
    A.3Full title of the trial
    Clinical trial for the assessment of delayed antibiotic treatment in the non-complicated acute respiratory tract infections in pediatric.
    Ensayo clínico sobre la evaluación de la prescripción diferida de antibióticos en las infecciones respiratorias agudas no complicadas en pediatría.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Delayed antibiotic prescription for respiratory infections in children.
    Prescripción antibiótica diferida en infecciones respiratorias en niños.
    A.3.2Name or abbreviated title of the trial where available
    DAP-pediatrics
    PDA-pediatría
    A.4.1Sponsor's protocol code numberPDA-pediatría
    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 SponsorAsociación Colaboración Cochrane Iberoamericana
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAsociación Colaboración Cochrane Iberoamericana
    B.5.2Functional name of contact pointPablo Alonso
    B.5.3 Address:
    B.5.3.1Street AddressSant Antoni Mª Claret 171
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.3.4CountrySpain
    B.5.4Telephone number0034935537808
    B.5.5Fax number0034935537809
    B.5.6E-mailpalonso@santpau.cat
    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 nameAntibiotic
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMOXICILLIN
    D.3.9.1CAS number 26787-78-0
    D.3.9.2Current sponsor codeJ01CA04
    D.3.9.3Other descriptive nameAmoxillin
    D.3.9.4EV Substance CodeSUB05481MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30 to not applicable
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPHENOXYMETHYLPENICILLIN
    D.3.9.1CAS number 87-08-1
    D.3.9.2Current sponsor codeJ01CE02
    D.3.9.3Other descriptive namePHENOXYMETHYLPENICILLIN
    D.3.9.4EV Substance CodeSUB09779MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    Uncomplicated respiratory tract infections in children.
    Infecciones respiratorias no complicadas en niños.
    E.1.1.1Medical condition in easily understood language
    Respiratory tract infections
    Infecciones respiratorias
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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 investigate whether a delayed antibiotic prescription strategy compared with traditional antibiotic prescription or no antibiotic prescription leads to a similar duration in the severity of symptoms in children with uncomplicated respiratory tract infections.
    Determinar el efecto de las diferentes estrategias de tratamiento antibiótico sobre la duración y gravedad de los síntomas en las infecciones respiratorias agudas no complicadas en pacientes pediátricos.
    E.2.2Secondary objectives of the trial
    Determinate the impact of the different treatment strategies/ Perceptions and attitudes about these treatment strategies/ The cost-effectiveness of the strategies/The number of additional medical visits/ The safety.
    Determinar el impacto de las diferentes estrategias de tratamiento/ Las percepciones y actitudes acerca de estas estrategias de tratamiento/ El coste-efectividad de las estrategias/ El número adicional de las visitas médicas/La seguridad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I) Children, up to 14 years, with uncomplicated respiratory infections: acute otitis media, rhinosinusitis, pharyngotonsillitis and acute bronchitis. II) To have reasonable doubts of the antibiotic prescription.
    I) Niños hasta los 14 años con infecciones respiratorias no complicadas: otitis media aguda, rinosinusitis, faringoamigdalitis y bronquitis aguda. II) Con dudas razonables de la necesidad de prescripción antibiótica.
    E.4Principal exclusion criteria
    I) Patients greater than or equal to 15 years of age. II) To be certain of the antibiotic prescription III) Pediatric patient with symptoms or signs suggestive of a serious condition and/or complications.
    I) Pacientes mayores o igual a 15 años de edad. II) Tener la certeza de la necesidad de prescripción antibiótica III) Pacientes pediátricos con síntomas o signos sugestivos de una enfermedad grave y / o complicaciones.
    E.5 End points
    E.5.1Primary end point(s)
    Duration and severity of symptoms
    Duración y severidad de los síntomas
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days.
    30 días.
    E.5.2Secondary end point(s)
    I) Antibiotic consumption II) Parents? satisfaction III) Parents' and pediatricians? belief in the efficacy of antibiotics IV) Perception of safety and efficacy V) Complications related to the infection process.
    I) Consumo de antibióticos II) Satisfacción de los padres III) Creencias de los pediatras y padres de los pacientes en la eficacia de los antibióticos IV) La percepción de la seguridad y la eficacia V) Complicaciones relacionadas con el proceso de infección.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days and after one year.
    30 días y al cabo de 1 año.
    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 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
    no antibióticos
    no antibiotics
    E.8.2.4Number of treatment arms in the trial3
    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 concerned15
    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
    1 year after the last visit
    1 año después de la última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 450
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 350
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    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
    Subjects under age incapable of giving consent personally.
    Sujetos incapaces de dar su consentimiento personalmente por la edad.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state450
    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)
    It isn't different from the expected normal treatment of that condition
    No será distinto al tratamiento habitual recibido para esta enfermedad
    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 Decision2012-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-13
    P. End of Trial
    P.End of Trial StatusOngoing
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