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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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:2021-004143-24
    Sponsor's Protocol Code Number:FIBHNJ-2021-01
    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:2022-03-11
    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 number2021-004143-24
    A.3Full title of the trial
    A Phase III, Multicenter, Randomized, Controlled, Open-label, Non-inferiority to Evaluate the Safety and Efficacy of Amoxicillin Ambulatory Short Treatment in Children with Acute Streptococcal Pharyngitis.
    Ensayo clínico fase iii abierto, aleatorizado, controlado, de no inferioridad, para evaluar la eficacia y seguridad de pautas cortas ambulatorias de amoxicilina en niños con faringoamigdalitis aguda estreptocócica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Short Treatment with Amoxicillin in Children with Acute Streptococcal Pharyngitis
    Pautas cortas de amoxicilina en niños con faringoamigdalitis aguda estreptocócica
    A.3.2Name or abbreviated title of the trial where available
    Short Treatment with Amoxicillin in Children with Acute Streptococcal Pharyngitis
    Pautas cortas de amoxicilina en niños con faringoamigdalitis aguda estreptocócica
    A.4.1Sponsor's protocol code numberFIBHNJ-2021-01
    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 SponsorHospital Universitario Niño Jesus
    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 supportFundación de Investigación Biomédica Hospital Niño Jesús
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación de Investigación Biomédica Hospital Niño Jesús
    B.5.2Functional name of contact pointJose Antonio Alonso Cadenas
    B.5.3 Address:
    B.5.3.1Street AddressMenendez Pelayo, 65
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28009
    B.5.3.4CountrySpain
    B.5.4Telephone number0034915035900314
    B.5.6E-mailjalonsoc@salud.madrid.org
    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 Amoxicillin
    D.2.1.1.2Name of the Marketing Authorisation holderAEMPS
    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 nameAmoxicillin
    D.3.2Product code J01CA04
    D.3.4Pharmaceutical form Oral solution
    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.3.9.4EV Substance CodeSUB05481MIG
    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 50
    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
    Acute Streptococcal Pharyngitis
    Faringoamigdalitis estreptocócica aguda
    E.1.1.1Medical condition in easily understood language
    Acute Streptococcal Pharyngitis
    Faringoamigdalitis estreptocócica aguda
    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 10034839
    E.1.2Term Pharyngitis streptococcal
    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
    • To evaluate whether short 5-day or 7-day oral amoxicillin treatment are not worse than 10-day treatment with respect to the incidence of relapse in patients aged 2 to 18 years with acute streptococcal pharyngitis.
    Evaluar de forma prospectiva y randomizada que las pautas cortas de 5 o 7 día de amoxicilina oral no son inferiores a la pauta de 10 días con respecto a la incidencia de recaídas en pacientes de entre 2 y 18 años con FAA estreptocócica.
    E.2.2Secondary objectives of the trial
    • To evaluate short 5-day or 7-day oral amoxicillin treatment are not worse than 10-day treatment with respect to cure rate in patients aged 2 to 18 years with acute streptococcal pharyngitis.
    • Compare the type and proportion of suppurative and non-suppurative complications among the different treatment groups.
    • Compare the adherence to the assigned treatment.
    • Compare the appearance of amoxicillin skin rashes in both groups.
    - Evaluar de forma prospectiva y randomizada que las pautas cortas de 5 o 7 día de amoxicilina oral no son inferiores a la pauta de 10 días con respecto a la tasa de curación
    - Describir el tipo y proporción de complicaciones supurativas y no supurativas entre los distintos grupos de tratamiento.
    - Describir el grado de adherencia al tratamiento asignado.
    - Describir la aparición de los exantemas cutáneos por amoxicilina en ambos grupos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female patients 2-17 (inclusive) years of age.
    • New diagnosis of acute streptococcal pharyngitis confirmed microbiologically by rapid antigen test with onset of symptoms not exceeding 72 hours before the start of study treatment.
    • McIsaac scale equal or greater than 2 points as long as there is fever ≥38ºC.
    • Voluntarily signed informed consent obtained from parents or legal guardians and assent in patients 12 years of age or older before any trial-related procedures are performed
    - Paciente varón o hembra ≥2 años y <18 años.
    - Paciente con nuevo diagnóstico de FAA por EbhGA confirmada microbiológicamente mediante TDR con inicio de síntomas no superior a las 72 horas antes del inicio del tratamiento del estudio
    - Escala de McIsaac (Apéndice C) mayor o igual a 2 puntos siempre y cuando exista fiebre ≥38ºC.
    - Consentimiento informado escrito obtenido de los padres o tutores legales y asentimiento en los pacientes de 12 años o más.
    E.4Principal exclusion criteria
    • To be receiving antibiotic treatment whose spectrum of action includes Streptococcus pyogenes (penicillin, amoxicillin, amoxicillin clavulanate, macrolides or first, second or third generation cephalosporins.
    • To have received treatment with any of the following medications in the previous 48 hours: probenecid, allopurinol, tetracyclines, oral anticoagulants or methotrexate.
    • Recurrent streptococcal pharyngitis: seven or more episodes of acute streptococcal pharyngitis per year in the last year, five or more episodes per year in the last two years, or three or more episodes per year in the last three years. In addition, each episode must keep at least one of the following criteria: tonsillar swelling or exudate, temperature >38ºC, tender anterior cervical adenopathy and positive throat culture for Streptococcal pyogenes.
    • A positive rapid antigen test or throat culture for Streptococcal pyogenes in the 28 days prior to initial care.
    • Patients with a personal history of suppurative and non-suppurative complications after acute streptococcal pharyngitis.
    • Patients with a personal history of invasive disease (bacteraemia, meningitis) due to Streptococcus pyogenes.
    • Immunosuppressed patient.
    • Impossibility of tracking.
    • Patients allergic to amoxicillin.
    • Parents, legal guardians or patients who cannot understand or comply with all the instructions and requirements of the study.
    • If in the opinion of the investigator there are findings in the physical examination, abnormalities in the results of clinical tests or other medical, social or psychosocial factors whose participation could put the patient´s health at risk.
    - Estar recibiendo tratamiento antibiótico cuyo espectro de acción incluye el EbhGA (penicilina, amoxicilina, amoxicilina-clavulánico, macrólidos o cefalosporinas de primera, segunda o tercera generación).
    - Haber recibido en las 48 horas previas tratamiento con alguno de los siguientes medicamentos: probenecid, alopurinol, tetraciclinas, anticoagulantes orales o metrotrexato.
    - FAA de repetición: siete o más episodios de amigdalitis aguda al año en el último año, cinco o más episodios al año en los últimos dos años o tres o más episodios al año en los últimos tres años. Además cada episodio debe cumplir al menos uno de los siguientes criterios: exudado purulento sobre las amígdalas, fiebre >38,3ºC, linfadenopatías cervicales anteriores, cultivo positivo para EbhGA.
    - FAA por EbhGA documentada microbiológicamante (TDR o cultivo faríngeo) en los 28 días anteriores a la atención inicial.
    - Pacientes con antecedentes personales de complicaciones supurativas y no supurativas tras una FAA estreptocócica.
    - Paciente con antecedente personal de enfermedad invasiva (bacteriemia, meningitis) por EbhGA.
    - Paciente inmunodeprimido.
    - Imposibilidad de seguimiento.
    - Pacientes alérgicos a la amoxicilina.
    - Padres/tutores legales y/o paciente que no puedan comprender ni cumplir con todas las instrucciones y requisitos del estudio.
    - Si en opinión del investigador existen hallazgos en la exploración física, anomalías en los resultados de los análisis clínicos u otros factores médicos, sociales o psicosociales cuya participación pudiera poner en riesgo la salud del paciente.
    E.5 End points
    E.5.1Primary end point(s)
    • Relapse: number of patients showing re-infection within 15 days after end of treatment
    • Recaída: pacientes con reinfección por el EbhGA antes de 15 días tras terminar la pauta antibiótica asignada
    E.5.1.1Timepoint(s) of evaluation of this end point
    15 days after study treatment start.
    15 días tras finalizar el tratamiento asignado.
    E.5.2Secondary end point(s)
    • Cure rate
    • Suppurative complications
    • Non-suppurative complications
    - tasa de curación
    - Aparición de complicaciones supurativas
    - Aparición de complicaciones no supurativas
    E.5.2.1Timepoint(s) of evaluation of this end point
    From 48h to 4 month after study treatment start.
    Desde 48h hasta 4 meses de empezar el tratamiento del estudio
    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) 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 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
    Standard of care
    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 concerned1
    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 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
    LVLS
    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 months16
    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: 710
    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: 360
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 350
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state710
    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)
    None
    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 Decision2022-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-26
    P. End of Trial
    P.End of Trial StatusOngoing
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