Not yet recruitingPHASE3INTERVENTIONAL

Efficacy of Non Operative Treatment With Amoxicillin/Clavulanic Acid Versus Surgical Treatment in Acute Uncomplicated Appendicitis in Children

This study is looking at the best way to treat children aged 5 to 14 who have appendicitis that isn't complicated. Usually, children with this condition might have surgery. However, studies suggest that antibiotics could work well for many, possibly leading to fewer side effects, less time out of school or activities, and lower healthcare costs. Researchers are comparing these two approaches. Some children in the study will have the usual appendectomy (surgery), while others will receive antibiotics first. Doctors will follow both groups closely to see which treatment is more effective and leads to better outcomes, including how often appendicitis comes back or if there are any complications.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

University Hospital, Toulouse

Enrolment target

724

Start

01 Sep 2026

Estimated completion

01 Sep 2034

Acute Uncomplicated Appendicitis

What is this study about?

When a child gets appendicitis – that's when their appendix becomes sore and swollen – doctors often recommend an operation to remove it. However, for a type called 'uncomplicated appendicitis,' where the appendix hasn't burst or caused other serious issues, some research suggests that antibiotics might be a good first step. These antibiotics could calm down the inflammation in the appendix without the need for surgery.

This study aims to find out if treating children with antibiotics first is just as good, or 'non-inferior,' to having an operation. Researchers believe that using antibiotics could lead to fewer problems after treatment, less time recovering, and might even be cheaper in the long run. They want to make sure that children get the best and safest care possible.

To do this, children who join the study will be split into two groups by chance. One group will have the standard operation, while the other group will receive a course of antibiotics. Doctors will then closely watch both groups to see how they recover, how long it takes, if they have any side effects, and if the appendicitis comes back. This careful comparison will help doctors understand if antibiotics can safely become a first-choice treatment for uncomplicated appendicitis in children.

Key takeaways

Compares antibiotics vs. surgery for uncomplicated appendicitis in children.
Aims to see if antibiotics can be an effective first treatment.
Could potentially lead to fewer complications and faster recovery for some.
Participation involves either surgery or an antibiotic course.
Medical team will closely monitor your child's health for one year.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for children aged between 5 and under 15 years old who have been diagnosed with their first episode of uncomplicated appendicitis. This means tests like an ultrasound or CT scan have shown their appendix is swollen but hasn't burst, formed an abscess, or caused other serious complications. They should be expected to have surgery within 24 hours of their diagnosis.

Children cannot join the study if they have other serious health problems, such as a weakened immune system, diabetes, or severe blood disorders. If they've already been treated with antibiotics for appendicitis, or if they have a known allergy to penicillin or similar antibiotics, they also won't be able to take part. Researchers also need to make sure families can keep up with follow-up appointments.

Parents or legal guardians must understand the study information in French, agree to their child participating, and the child should also agree if they are able. It's important that all these conditions are met to ensure the study is safe and effective for everyone involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 5 and 14 years old?
Has your child been diagnosed with uncomplicated appendicitis for the first time?
Does your child not have other serious health problems like a weakened immune system or severe blood issues?
Does your child not have an allergy to penicillin or similar antibiotics?
Are you able to agree to follow-up appointments and phone calls for one year?

Answer every question to see your result.

What does participation involve?

If your child joins this study, they will be randomly assigned to one of two groups. One group will have a standard operation to remove their appendix, usually within 24 hours. The other group will start on antibiotics. These antibiotics will first be given through a drip (intravenous) for about 1 to 2 days while your child is in hospital, and then they'll switch to antibiotic medicine by mouth (oral) for a total course of 7 days.

Both groups will have hospital visits on Day 1 and when they are discharged. There will be another hospital visit between 10 and 15 days after joining the study for a check-up. We'll also ask parents to fill out questionnaires about how their child is doing and any time off work they might have needed. Later, there will be phone calls to check in at 1 month, 6 months, and 12 months to see how your child is recovering, if they've had any side effects, or if the appendicitis has returned. We'll follow your child's progress for a total of one year.

Potential risks and benefits

Taking part in any study has potential benefits and risks. Your child might benefit from getting treatment that is carefully monitored and could potentially lead to a quicker recovery or fewer complications compared to standard care. However, there's always a risk that the treatment might not work as expected, or that new side effects could occur. For example, children in the antibiotic group might find their appendicitis comes back, and they still need surgery. For ethical reasons, you and your child can withdraw from the study at any time, for any reason, without it affecting your child's medical care.

Locations (10)

CHU de Bordeaux - Pellerin
Verified postcode
Bordeaux, France
Centre Hopsitalier Universitaire de Grenoble - Hôpital Nord
Verified postcode
Grenoble, France
Centre Hospitalier Universitaire de Lille - Hôpital Salengro
Verified postcode
Lille, France
Centre Hospitalier Universitaire de Limoges
Verified postcode
Limoges, France
AP-HM Hopital Nord
Verified postcode
Marseille, France
Centre Hospitalier Universitaire - Hôpital Lapeyronie
Verified postcode
Montpellier, France
Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu
Verified postcode
Nantes, France
AP-HP Hôpital Trousseau
Verified postcode
Paris, France
Centre Hospitalier Régional Universitaire de Rennes
Verified postcode
Rennes, France
Centre Hospitalier Universitaire
Verified postcode
Toulouse, France

Common questions

What is uncomplicated appendicitis?

This is when the appendix is inflamed but hasn't burst, formed an abscess, or caused other serious problems yet.

Will my child definitely take antibiotics if we join?

No, your child will be randomly assigned to either receive antibiotics or have surgery. You won't be able to choose.

How long will my child be monitored during the study?

Your child will be followed for a full year after starting the treatment, with a few visits and phone calls.

What if the antibiotics don't work?

If antibiotics don't work or your child's condition worsens, they will likely need surgery. This will be closely monitored by the medical team.

Is surgery for appendicitis always the best option?

Surgery is the standard treatment. This study is trying to find out if antibiotics can be just as good and potentially avoid the need for an operation for some children.

How to find out more

Nadège ALGANS

algans.n@chu-toulouse.fr 0561777204 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.