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    Summary
    EudraCT Number:2021-005490-30
    Sponsor's Protocol Code Number:PP21/14
    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:2022-02-11
    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 number2021-005490-30
    A.3Full title of the trial
    EFFECTIVENESS OF TREATMENT WITH ANTISEPTICS VERSUS TOPICAL ANTIBIOTICS IN MILD IMPETIGO IN PEDIATRIC PATIENTS
    EFECTIVIDAD DEL TRATAMIENTO CON ANTISÉPTICOS FRENTE A ANTIBIÓTICOS TÓPICOS EN EL IMPÉTIGO LEVE EN PACIENTES PEDIÁTRICOS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECTIVENESS OF TREATMENT WITH ANTISEPTICS VERSUS ANTIBIOTICS IN MILD IMPETIGO IN CHILDREN.
    EFECTIVIDAD DEL TRATAMIENTO CON ANTISÉPTICOS FRENTE A ANTIBIÓTICOS EN EL IMPÉTIGO LEVE EN NIÑOS
    A.4.1Sponsor's protocol code numberPP21/14
    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 Son Llàtzer
    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 supportHospital Universitario Son Llàtzer
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Son Llàtzer
    B.5.2Functional name of contact pointSara Melgar Diaz
    B.5.3 Address:
    B.5.3.1Street AddressCrta. Manacor km.4.
    B.5.3.2Town/ cityPalma
    B.5.3.3Post code07198
    B.5.3.4CountrySpain
    B.5.6E-mailsara.melgardiaz@gmail.com
    D. IMP Identification
    D.IMP: 1
    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 1% aqueous chlorhexidine.
    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 Concentrate for cutaneous spray, emulsion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous 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.IMP: 2
    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 2% fusidic acid cream
    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 Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous 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
    Impetigo is a bacterial infection of very common skin in the pediatric population. In the usual clinical practice, the treatment of this infection has been based on topical antibiotics. The widespread use of antibiotics contributes to the increase of resistance. Focusing on the forms of localized impetigo, there are studies that suggest that treatment with topical antiseptics could be a good treatment option.
    El impétigo es una infección bacteriana de la piel muy habitual en la población pediátrica. En la práctica clínica habitual, el tratamiento de esta infección se ha basado con antibióticos tópicos. El uso generalizado de los antibióticos contribuye al aumento de resistencias. Centrándonos en las formas de impétigo localizado, hay estudios que sugieren que el tratamiento con antisépticos tópicos podría ser una buena opción de tratamiento.
    E.1.1.1Medical condition in easily understood language
    Impétigo is a bacterial skin infection in children. The most common treatment has been based on antibiotics. Instead it seems that treatment with antiseptics could be a good treatment option.
    El impétigo es una infección bacteriana de la piel en los niños. El tratamiento más habitual se basa en antibióticos. En cambio parece que el tratamiento con antisépticos podría ser una buena opción.
    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
    Evaluate the efficacy of treatment with topical antiseptics versus topical antibiotherapy in the treatment of mild impétigo of pediatric age.
    Evaluar la eficacia del tratamiento con antisépticos tópicos frente a la antibioterapia tópica en el tratamiento del impétigo leve en edad pediátrica.
    E.2.2Secondary objectives of the trial
    - Know the remission time of impetigo in the two treatment arms.
    - Know the percentage of impregites that evolve in each arm and specify another line of treatment.
    - Determine the causative bacterial agent of impestight with bad initial evolution.
    - Determine the cost-effectiveness of treatment with topical antiseptic.
    - Conocer el tiempo de remisión del impétigo en los dos brazos de tratamiento.
    - Conocer el porcentaje de impétigos que evolucionan en cada brazo y precisan otra línea de tratamiento.
    - Determinar el agente bacteriano causal de los impétigos con mala evolución inicial.
    - Determinar el coste-efectividad del tratamiento con antiséptico tópico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients who consult in the pediatric emergency service, who meet the following criteria:
    - Age between 1 year and 13 years (inclusive).
    - Patients diagnosed with localized non-bullous impetigo.
    - Not having received previous antibiotic treatment for the same episode.
    - Parents / legal guardians who agree to participate in the study and sign the informed consent, after the relevant explanation of the study.
    Todos los pacientes que consulten en el servicio de urgencias de pediatría, que cumplan los siguientes criterios:
    - Edad comprendida entre 1 año y 13 años (inclusive).
    - Pacientes diagnosticados de impétigo localizado no ampolloso.
    - No haber recibido tratamiento antibiótico previo para el mismo episodio.
    - Padres / tutores legales que aceptan participar en el estudio y firmen el consentimiento informado, tras la explicación pertinente del estudio y tras recibir la hoja informativa.
    E.4Principal exclusion criteria
    Patients under one year of age or over 14 years of age.
    - Children with comorbidities (corticosteroid treatment, chronic pathology ...)
    - Patients who have received previous antibiotic treatment in the same episode
    - Patients with extensive / severe impetigo or bullous forms.
    -Lesions in particular locations, such as the periocular area or areas of sensitive skin, not subsidiary to treatment with topical antiseptic.
    -Parents / guardians who do not agree to participate in the study or revoke the signature of the informed consent.
    Pacientes menores de un año de edad o mayores de 14 años.
    - Niños con comorbilidades (tratamiento corticoideo, patología crónica…)
    - Pacientes que hayan recibido tratamiento antibiótico previo en el mismo episodio
    - Pacientes con impétigos extensos/graves o formas ampollosas.
    -Lesiones en localizaciones particulares, como la zona periocular o zonas de piel sensible, no subsidiarias de tratamiento con antiséptico tópico.
    -Padres/tutores que no acepten participar en el estudio o revoquen la firma del consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    the effectiveness of the treatment:
    - Response of injuries to treatment (0 Inadequate, 1 adequate)
    - Evolution to serious forms (extensive lesions, staphylococcal scald ...)
    - Adverse effects according to treatment (0 no, 1 yes)
    - Requires entry (0 no, 1 Yes)
    - Culture is collected (0 no, 1 Yes)
    - Positive culture (0 no, 1 Yes)
    - Causal agent (0 Staphylococcus, 1 Streptococcus, 2 others)
    - Result antibiogram (determine the causative agent)
    la eficacia del tratamiento:
    - Respuesta de las lesiones al tratamiento (0 Inadecuada, 1 adecuada)
    - Evolución a formas graves (lesiones extensas, escaldadura estafilocócica...)
    - Efectos adversos según tratamiento (0 no, 1 si)
    - Precisa ingreso (0 no, 1 Si)
    - Se recoge cultivo (0 no, 1 Si)
    - Cultivo positivo (0 no, 1 Si)
    - Agente causal (0 Estafilococo, 1 estreptococo, 2 otros)
    - Resultado antibiograma (determinar el agente causal)
    E.5.1.1Timepoint(s) of evaluation of this end point
    the effectiveness of the treatment will be measured at 72 hours and subsequently at 7 days.
    La eficacia del tratamiento se medirá a las 72 horas y posteriormente a los 7 días.
    E.5.2Secondary end point(s)
    DEMOGRAPHIC VARIABLES:
    - Patient history number
    - Age (in months)
    - Sex (0 female, 1 male)
    - Person in charge of treatment at home (0 Mother, 1 Father, 2 both indistinctly, 3 another relative, own patient)
    - History of atopy (0 No, 1 Yes)
    - Drug allergies (0 No, 1 Yes)
    - Other allergies (0 No, 1. Yes)

    VARIABLES PRIOR TO TREATMENT
    - Treatment that the patient will receive (0. Topical antibiotic - odd days of the month; 1. Antiseptic - Even days of the month).
    - Injury area (0.face, 1.legs, 2. Trunk)
    - Initial injury (0 sting, 1 nonspecific injury, 2 do not remember that there was injury)
    - Days of evolution of the lesions (in hours)
    - Reconsultation for injuries (previously visit in health center or emergency room) (0 no, 1 Yes).
    VARIABLES DEMOGRÁFICAS:
    - Número de historia del paciente
    - Edad (en meses)
    - Sexo (0 mujer, 1 hombre)
    - Persona que se encarga del tratamiento en domicilio (0 Madre, 1 Padre, 2 ambos indistintamente, 3 otro familiar, propio paciente)
    - Antecedentes de atopia ( 0 No, 1 Si)
    - Alergias medicamentosas (0 No, 1 Sí)
    - Otras alergias (0 No, 1. Si)

    VARIABLES PREVIAS AL TRATAMIENTO
    - Tratamiento que recibirá el paciente (0. Antibiótico tópico -días impares del mes; 1. Antiséptico – Días pares del mes).
    - Zona de la lesión (0.cara, 1.extremidades, 2. Tronco)
    - Lesión inicial (0.picadura, 1 herida inespecífica, 2 no recuerdan que hubiera lesión)
    - Días de evolución de las lesiones (en horas)
    - Reconsulta por las lesiones (previamente visita en centro de salud o urgencias) (0 no, 1 Si).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The demographic variables and the variables prior to treatment will be measured at the moment of inclusion of the patient, in the visit 0.
    Las variables demográficas y las variables previas al tratamiento se medirán en el momento de inclusión del paciente, en la visita 0.
    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 No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial20
    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
    The study will have a minimum duration of data collection of 12 months.
    El estudio tendrá una duración mínima de recogida de datos de 12 meses.
    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 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: 40
    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) Information not present in EudraCT
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state40
    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 Decision2022-04-28
    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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