Acute Streptococcal Pharyngitis MedDRA version: 20.0 Level: PT Classification code 10034839 Term: Pharyngitis streptococcal System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Amoxicillin
Product Name: Amoxicillin
Product Code: J01CA04
Pharmaceutical Form: Oral solution
INN or Proposed INN: AMOXICILLIN
CAS Number: 26787-78-0
Concentration unit: mg/kg milligram(s
Sponsors
Hospital Universitario Niño Jesus
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? yes Number of subjects for this age range: 710 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • 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.;Secondary Objective: • 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.;Primary end point(s): • Relapse: number of patients showing re-infection within 15 days after end of treatment;Timepoint(s) of evaluation of this end point: 15 days after study treatment start. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Cure rate • Suppurative complications • Non-suppurative complications;Timepoint(s) of evaluation of this end point: From 48h to 4 month after study treatment start. | — |
Countries
Spain
Contacts
Public ContactJose Antonio Alonso Cadenas
Fundación de Investigación Biomédica Hospital Niño Jesús
Outcome results
None listed