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Study to evaluate shorter courses of amoxicillin in children with streptococcal throat infection
EU CTIS ID: 2026-525355-93-00
What this study is testing
Prospectively and randomly evaluate that the short 5-day course of oral amoxicillin is not inferior to the 7-day course with regard to the incidence of relapses in patients aged 2 to 17 years with streptococcal FAA.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patients aged ≥2 years and <18 years
- Patients with a new diagnosis of FAA due to EbhGA confirmed microbiologically by TDR with onset of symptoms no more than 72 hours prior to the start of study treatment.
- McIsaac scale greater than or equal to 3 points provided there is a fever >38°C
- Written informed consent obtained from parents or legal guardians and assent from patients aged 12 years or older
You likely can't join if
- Being treated with antibiotics whose spectrum of action includes EbhGA (penicillin, amoxicillin, amoxicillin-clavulanic acid, macrolides or first-, second- or third-generation cephalosporins).
- Impossibility of follow-up
- Patients allergic to amoxicillin
- Parents/legal guardians and/or patients who are unable to 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 clinical test results, or other medical, social, or psychosocial factors whose participation could put the patient's health at risk
- Having received treatment with any of the following medications in the previous 48 hours: probenecid, allopurinol, tetracyclines, oral anticoagulants or methotrexate.
See the full eligibility criteria
- Male or female patients aged ≥2 years and <18 years
- Patients with a new diagnosis of FAA due to EbhGA confirmed microbiologically by TDR with onset of symptoms no more than 72 hours prior to the start of study treatment.
- McIsaac scale greater than or equal to 3 points provided there is a fever >38°C
- Written informed consent obtained from parents or legal guardians and assent from patients aged 12 years or older
- Being treated with antibiotics whose spectrum of action includes EbhGA (penicillin, amoxicillin, amoxicillin-clavulanic acid, macrolides or first-, second- or third-generation cephalosporins).
- Impossibility of follow-up
- Patients allergic to amoxicillin
- Parents/legal guardians and/or patients who are unable to 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 clinical test results, or other medical, social, or psychosocial factors whose participation could put the patient's health at risk
- Having received treatment with any of the following medications in the previous 48 hours: probenecid, allopurinol, tetracyclines, oral anticoagulants or methotrexate.
- Showing signs and/or symptoms of viral infection: rhinorrhoea, cough, conjunctivitis, dysphonia, acute stomatitis, ulcerative lesions or vesicles in the mouth and/or diarrhoea
- Recurrent AAD: seven or more episodes of acute tonsillitis 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 meet at least one of the following criteria: purulent exudate on the tonsils, temperature >38°C, anterior cervical lymphadenopathy, positive culture for EbhGA
- FAA due to microbiologically documented EbhGA (rapid diagnostic test or throat culture) within 28 days prior to initial care
- Patients with a personal history of suppurative and non-suppurative complications following streptococcal FAA
- Patients with a personal history of invasive disease (bacteremia, meningitis) caused by EbhGA
- Immunocompromised patients
- Pregnant or breastfeeding women
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.