E.1 Medical condition or disease under investigation |
E.1.1 | Medical 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. |
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E.1.1.1 | Medical 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. |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary 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) |
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E.5.1.1 | Timepoint(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. |
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E.5.2 | Secondary 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). |
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E.5.2.1 | Timepoint(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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 20 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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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. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |