Short Treatment with Amoxicillin in Children with Acute Streptococcal Pharyngitis

Phase 1

• Conditions: Acute Streptococcal Pharyngitis; MedDRA version: 20.0Level: PTClassification code 10034839Term: Pharyngitis streptococcalSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-004143-24-ES
• Lead Sponsor: Hospital Universitario Niño Jesus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-11
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 710

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified