E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Streptococcal Pharyngitis |
Faringoamigdalitis estreptocócica aguda |
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E.1.1.1 | Medical condition in easily understood language |
Acute Streptococcal Pharyngitis |
Faringoamigdalitis estreptocócica aguda |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10034839 |
E.1.2 | Term | Pharyngitis streptococcal |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
• 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. |
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E.2.2 | Secondary 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
15 days after study treatment start. |
15 días tras finalizar el tratamiento asignado. |
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E.5.2 | Secondary end point(s) |
• Cure rate • Suppurative complications • Non-suppurative complications |
- tasa de curación - Aparición de complicaciones supurativas - Aparición de complicaciones no supurativas |
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E.5.2.1 | Timepoint(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 |
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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 | Yes |
E.6.4 | Safety | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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
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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 | |
E.8.9.1 | In the Member State concerned months | 16 |
E.8.9.1 | In the Member State concerned days | |