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Could antibiotics replace surgery for Kids' appendicitis?

NCT ID NCT07587450

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 724 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2034

An estimate. End dates often move.

Lead sponsor

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

5 to 14 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • AP-HM Hopital Nord

    Marseille, France

  • AP-HP Hôpital Trousseau

    Paris, France

  • CHU de Bordeaux - Pellerin

    Bordeaux, France

  • Centre Hopsitalier Universitaire de Grenoble - Hôpital Nord

    Grenoble, France

  • Centre Hospitalier Régional Universitaire de Rennes

    Rennes, France

  • Centre Hospitalier Universitaire

    Toulouse, France

  • Centre Hospitalier Universitaire - Hôpital Lapeyronie

    Montpellier, France

  • Centre Hospitalier Universitaire de Lille - Hôpital Salengro

    Lille, France

  • Centre Hospitalier Universitaire de Limoges

    Limoges, France

  • Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu

    Nantes, France

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