Efficacy of Non Operative Treatment With Amoxicillin/Clavulanic Acid Versus Surgical Treatment in… (NCT07587450) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Efficacy of Non Operative Treatment With Amoxicillin/Clavulanic Acid Versus Surgical Treatment in Acute Uncomplicated Appendicitis in Children
France724 participantsStarted 2026-09-01
Plain-language summary
The majority of children with uncomplicated acute appendicitis may be considered for either a non-operative or an operative management. The antibiotic-first strategy appears effective as an initial treatment in 97% of children with uncomplicated AA (recurrence rate 14%), with Non Operative Treatment (NOT) also leading to less morbidity, fewer disability days, and lower costs than surgery. In this trial, the investigators will compare children randomised in a surgery group with children randomised in a NOT group (antibiotic strategy group). Children have 2 on-site visits (including surgery) in the first 12 days with recording of clinical datas and questionnaires, a phone visit at month 1, month 6, month 12 to collect concomitant treatment, Adverse Event (AE) and complications and parental questionnaires at the end of the study. A Cost-Utility analysis will be performed from the healthcare payer's perspective. The time horizon of the medico economic analysis was one year.
Who can participate
Age range
5 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age from 5 to \<15 years-old
* Diagnosis of first episode of acute uncomplicated appendicitis confirming the diagnosis:
* an increase in the calibre of the appendix, measured at more than 6 mm in diameter and non-compressibility
* free fluid, echogenic fat, regional hyperemia
* performed in hospital or reviewed by local radiologist investigators if performed outpatient.
* Surgery expected within 24 hours after diagnosis
* Parental good understanding of the monitoring French instructions
* Free and informed consent, signed by both holders of parental authority/legal representative, with the accord of the minor patient.
* Affiliation to the health insurance plan
Exclusion Criteria:
* Ultrasound or CT scan showing one or several stercoliths, a plastron, an abscess or peritonitis
* Non-visualization of the appendix at ultrasound or CT scan
* Situations contraindicating surgery or anesthesia (patient for whom surgery and anesthesia would pose a life-threatening risk)
* Patients who have already received antibiotic therapy for acute appendicitis
* Known immunodepression, ongoing immunosuppressive treatment, diabetes
* Severe hematologic disorders (such as bone marrow failure, blood clotting disorders)
* History of proved allergy to Penicillin
* History of proved allergy to amoxicillin and/or clavulanic acid
* History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or mono…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of treatment-related failures at one year