Study to evaluate shorter courses of amoxicillin in children with streptococcal throat infection

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Decision date (initial)

2026-06-08

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 4

1. To prospectively and randomly evaluate that the short 5-day course of oral amoxicillin is not inferior to the 7-day course in terms of cure rate in patients aged 2 to 17 years with FAA due to EbhGA.
2. To describe the type and proportion of suppurative and non-suppurative complications among the different treatment groups
3. To describe the degree of adherence to the assigned treatment
4. To describe the occurrence of amoxicillin-induced skin rashes in both groups

Conditions and MedDRA coding

ACUTE STREPTOCOCCAL PHARYNGOTONSILLITIS

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male or female patients aged ≥2 years and <18 years
2. 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.
3. McIsaac scale greater than or equal to 3 points provided there is a fever >38°C
4. Written informed consent obtained from parents or legal guardians and assent from patients aged 12 years or older

Exclusion criteria 13

1. Being treated with antibiotics whose spectrum of action includes EbhGA (penicillin, amoxicillin, amoxicillin-clavulanic acid, macrolides or first-, second- or third-generation cephalosporins).
2. Having received treatment with any of the following medications in the previous 48 hours: probenecid, allopurinol, tetracyclines, oral anticoagulants or methotrexate.
3. Showing signs and/or symptoms of viral infection: rhinorrhoea, cough, conjunctivitis, dysphonia, acute stomatitis, ulcerative lesions or vesicles in the mouth and/or diarrhoea
4. 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
5. FAA due to microbiologically documented EbhGA (rapid diagnostic test or throat culture) within 28 days prior to initial care
6. Patients with a personal history of suppurative and non-suppurative complications following streptococcal FAA
7. Patients with a personal history of invasive disease (bacteremia, meningitis) caused by EbhGA
8. Immunocompromised patients
9. Pregnant or breastfeeding women
10. Impossibility of follow-up
11. Patients allergic to amoxicillin
12. Parents/legal guardians and/or patients who are unable to understand or comply with all the instructions and requirements of the study
13. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Relapse: patients with reinfection by EbhGA within 15 days after completing the assigned antibiotic regimen.

Secondary endpoints 4

1. Cure: number of patients with fever resolution 48 hours after starting the assigned antibiotic regimen.
2. Suppurative complications. Suppurative complications are defined as: o Acute cellulitis. o Acute otitis media. o Acute sinusitis. o Acute mastoiditis. o Acute suppurative cervical adenitis. o Acute peritonsillar or retropharyngeal abscess. o Acute meningitis. o Acute cerebral abscess. o Acute thrombosis of the intracranial venous sinuses. o Acute streptococcal pneumonia. o Acute suppurative arthritis. o Acute osteomyelitis. o Acute liver abscess. o Acute endocarditis.
3. Non-suppurative complications. Non-suppurative complications are defined as: o Acute rheumatic fever (Diagnostic criteria - Appendix B). o Acute post-streptococcal glomerulonephritis. o Acute post-streptococcal reactive arthritis. o Erythema nodosum. o Anaaphylactoid purpura. o PANDAS syndrome.
4. New episodes of streptococcal FAA: presence of new episodes with TDR or positive throat culture for EbhGA during the 4-month follow-up period.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus

Sponsor organisation

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus

Address

Avenida Menendez Pelayo 65

City

Madrid

Postcode

28009

Country

Spain

Scientific contact point

Organisation

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus

Contact name

Gina Paola Mejía Abril

Public contact point

Organisation

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus

Contact name

Gina Paola Mejía Abril

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications