Amoxicillin; Clavulanic acid for Acute uncomplicated appendicitis

Inclusion criteria

• {"criterion_text":"- Age from 5 to <15 years-old\n- Diagnosis of first episode of acute uncomplicated appendicitis (abdominal pain, non-septic clinical aspect: good general condition, normal haemodynamic status, normal diuresis evaluated at clinical examination., and ultrasound and biology or CT scan (in cases where the appendix is not visible on ultrasound) confirming the diagnosis: \t- an increase in the calibre of the appendix, measured at more than 6 mm in diameter and non-compressibility \t- free fluid, echogenic fat, regional hyperemia \t- performed in hospital or reviewed by local radiologist investigators if performed outpatient.)\n- Surgery expected within 24 hours after diagnosis\n- Parental good understanding of the monitoring French instructions\n- Free and informed consent, signed by both holders of parental authority/legal representative, with the accord of the minor patient\n- Affiliation to the health insurance plan"}

Exclusion criteria

• {"criterion_text":"- Ultrasound or CT scan showing one or several stercoliths, a plastron, an abscess or peritonitis\n- Presence of an appendicolith\n- situations contraindicating surgery or anesthesia (patient for whom surgery and anesthesia would pose a life-threatening risk)\n- patients who have already received antibiotic therapy for acute appendicitis/ongoing immunosuppressive treatment\n- Mental state rendering the person giving consent incapable of understanding the trial\n- Parents being a relative of the investigator or a relative of someone from the team directly involved in the trial, including assistant doctors, pharmacists, nurses, and trial coordinators\n- Simultaneously participation in another research study involving medicinal products\n- Non-visualization of the appendix at ultrasound or CT scan\n- Known immunodepression, ongoing immunosuppressive treatment, diabetes\n- Severe hematologic disorders (such as bone marrow failure, blood clotting disorders)\n- o\tHistory of proved allergy to Penicillin \tHistory of proved allergy to amoxicillin and/or clavulanic acid \tHistory of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam). \tHistory of jaundice/hepatic impairment due to amoxicillin/clavulanic acid\tHistory of allergy to any of the excipients listed in section 6.1 of each SmPC.\n- On going antibiotherapy : previous antibiotherapy have to be stopped at least 48h before inclusion\n- Parental refusal of research protocol\n- Impossibility of home follow-up after discharge from hospital\n- Renal insufficiency with creatinine clearance < 30 mL/min\n- Pregnancy/ breastfeeding"}

Primary endpoints

• {"endpoint_text":"- percentage of treatment-related failures at one year defined as : -\tsecondary surgery, -\tIn surgery group, a normal appendix based on pathology or a complication requiring a new general anaesthesia -\tReadmissions for suspected appendicitis, emergency room visits related to appendicitis treatment, postoperative infections, adverse effects of antibiotics, adverse effects of anesthesia","definition_or_measurement_approach":"Percentage of treatment-related failures measured at one year, defined as: secondary surgery; in surgery group, a normal appendix based on pathology or a complication requiring a new general anaesthesia; readmissions for suspected appendicitis, emergency room visits related to appendicitis treatment, postoperative infections, adverse effects of antibiotics, adverse effects of anesthesia."}

Secondary endpoints

• {"endpoint_text":"- Differential cost-utility ratio between the two groups of treatment at one year","definition_or_measurement_approach":"Cost-utility analysis comparing the two treatment groups at one year (time horizon: 12 months, payer's perspective indicated in objectives)."}
• {"endpoint_text":"- Direct Medical costs, and indirect costs (parental absenteeism) descriptions at 1 year","definition_or_measurement_approach":"Measurement of direct medical costs and indirect costs (parental absenteeism) at 1 year."}
• {"endpoint_text":"- Using consumption data available in SNDS database, describe child care pathways over 5 years : Rehospitalization, appendectomy","definition_or_measurement_approach":"Analysis of healthcare consumption using SNDS database to describe child care pathways over 5 years (e.g., rehospitalization, appendectomy)."}
• {"endpoint_text":"- Incidence of adverse events at day 30 and at one year in the two groups, and incidence of adverse events due to antibiotics in the NOT group","definition_or_measurement_approach":"Incidence of adverse events measured at day 30 and at one year in both groups; additionally incidence of adverse events attributable to antibiotics in the Non Operative Treatment (NOT) group."}

France

Earliest CTIS Part Ii Submission Date

04-07-2025

Latest Decision Or Authorization Date

17-10-2025

Processing Time Days

105

Number Of Sites

10

Number Of Participants

724

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Toulouse

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France