Could antibiotics replace surgery for Kids' appendicitis?
NCT ID NCT07587450
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether treating children with uncomplicated appendicitis using antibiotics alone works as well as surgery. About 724 children aged 5 to 15 will be randomly assigned to receive either antibiotics or an operation. The goal is to see if the antibiotic approach leads to fewer complications, faster recovery, and lower costs, while still being effective.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 724 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2034
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 14 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 monobactam). * History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid * History of allergy to any of the excipients listed in section 6.1 of each SmPC. * On going antibiotherapy : previous antibiotherapy have to be stopped at least 48h before inclusion * Parental refusal of research protocol * Impossibility of home follow-up after discharge from hospital * Pregnancy/ breastfeeding * Simultaneously participation in another research study involving medicinal products * Mental state rendering the person giving consent incapable of understanding the trial * 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 * Renal insufficiency with creatinine clearance \< 30mL/min * Presence of an appendicolith
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AP-HM Hopital Nord
Marseille, France
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AP-HP Hôpital Trousseau
Paris, France
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CHU de Bordeaux - Pellerin
Bordeaux, France
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Centre Hopsitalier Universitaire de Grenoble - Hôpital Nord
Grenoble, France
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Centre Hospitalier Régional Universitaire de Rennes
Rennes, France
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Centre Hospitalier Universitaire
Toulouse, France
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Centre Hospitalier Universitaire - Hôpital Lapeyronie
Montpellier, France
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Centre Hospitalier Universitaire de Lille - Hôpital Salengro
Lille, France
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Centre Hospitalier Universitaire de Limoges
Limoges, France
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Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu
Nantes, France
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