Study comparing amoxicillin/clavulanic acid treatment versus surgery for children with uncomplicated appendicitis

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What is this study about?

This study focuses on children with uncomplicated appendicitis, comparing two different treatment approaches. The first approach involves medication using amoxicillin/clavulanic acid, while the second approach involves surgical removal of the appendix. The medication can be given both through a vein (intravenously) and by mouth as a liquid suspension or tablets.

The purpose of this research is to determine if treating appendicitis with antibiotics is as effective as surgery in children. The study will monitor children for one year after treatment. During treatment, patients receiving antibiotics will first get the medication through a vein for up to two days, followed by oral medication that can be taken at home.

If antibiotics are not effective, cefoxitin may be used as an alternative medication. The study will track how well each treatment works and any problems that might occur. This includes checking if patients need additional treatment, develop infections, or experience any unwanted effects from either the antibiotics or surgery.

1 Initial treatment phase

After diagnosis of uncomplicated appendicitis, you will be assigned to one of two treatment groups:

Group 1 – Non-surgical treatment: You will receive amoxicillin/clavulanic acid through an IV (intravenous) line at a dose of 80mg/kg/day for 24-48 hours

Group 2 – Surgical treatment: You will undergo an appendix removal operation

2 Continuation of medical treatment (Group 1 only)

After the IV treatment, you will switch to oral amoxicillin/clavulanic acid

The oral medication will be taken three times daily at a total dose of 80mg/kg/day

3 30-day follow-up

Your health status will be evaluated after 30 days

Any side effects from the treatment will be documented

4 One-year follow-up

Your health status will be evaluated after one year

The assessment will include checking for any treatment-related issues or complications

Documentation of any hospital visits or additional treatments related to appendicitis

5 Extended monitoring

Your medical care information will be monitored for up to 5 years

This includes tracking any hospital stays or additional appendix-related procedures

Who Can Join the Study?

  • Child must be between 5 and 14 years old
  • Must be experiencing first episode of uncomplicated appendicitis with:
    • Abdominal pain
    • Good general condition
    • Normal blood pressure and heart rate
    • Normal urine output
  • Must have confirmation of appendicitis through:
    • Ultrasound showing enlarged appendix (more than 6 mm wide)
    • Or CT scan (if appendix cannot be seen on ultrasound)
  • Surgery must be planned within 24 hours of diagnosis
  • Parents must be able to understand and follow monitoring instructions
  • Both parents or legal guardians must sign informed consent form
  • Child must agree to participate
  • Must have valid health insurance coverage

Who Cannot Join the Study?

  • Age below 6 years or above 18 years
  • Signs of complicated appendicitis (such as perforation – a hole in the appendix, or peritonitis – infection of the abdominal cavity)
  • Known allergy to amoxicillin/clavulanic acid or other penicillin antibiotics
  • Previous appendectomy (surgical removal of appendix)
  • Pregnancy or breastfeeding
  • Severe chronic diseases affecting immune system
  • Inability to take oral medications
  • Current use of antibiotics for other conditions
  • Symptoms lasting more than 48 hours
  • Severe abdominal pain requiring immediate surgery
  • Other diagnosed abdominal conditions requiring different treatment
  • Mental conditions that prevent understanding of treatment consent
  • Participation in other clinical trials within past 30 days

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Montpellier Montpellier France
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
03.11.2025

Trial locations

Amoxicillin/clavulanic acid is an antibiotic combination medication used to treat bacterial infections. In this trial, it is being studied as a non-surgical treatment option for acute uncomplicated appendicitis in children. The medication works by killing bacteria and preventing their growth. It is given both intravenously (through a vein) and orally (by mouth) during the course of treatment.

Surgical treatment is the standard approach for appendicitis, which involves the surgical removal of the inflamed appendix (appendectomy). This procedure is typically performed under general anesthesia and is being compared to the antibiotic treatment in this study.

Investigated diseases:

Appendicitis – An inflammation of the appendix, which is a small, finger-shaped pouch connected to the large intestine. The condition begins when the appendix becomes blocked, typically by stool, foreign objects, or infection, leading to inflammation. Uncomplicated appendicitis refers to the early stage of the condition where the appendix is inflamed but hasn’t burst. The inflammation causes the appendix to fill with pus and become swollen. This condition typically begins with pain near the navel that moves to the lower right abdomen, often accompanied by loss of appetite, nausea, and fever.

Trial ID:
2024-519402-12-00
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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