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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 3

    30-day follow-up

    Your health status will be evaluated after 30 days

    Any side effects from the treatment will be documented

  4. Step 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. Step 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 trial?

12 criteria

  • 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 trial?

13 criteria

  • 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
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Investigated drugs

  • 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.

What is already known about the treatment

Amoxicillin/Clavulanic acid – A combination antibiotic medication that is administered both intravenously (IV) and orally (PO) in the treatment of uncomplicated appendicitis, particularly in children as an alternative to surgery. This broad-spectrum antibiotic belongs to the penicillin class of drugs, where amoxicillin works by preventing bacterial cell wall formation, while clavulanic acid helps prevent bacterial resistance by blocking certain enzymes. The medication is typically administered first through IV infusion for 24-48 hours at a dosage of 80mg/kg/day, followed by oral administration in three daily doses, representing a non-operative treatment approach that may help avoid surgical intervention in certain cases of appendicitis.

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 detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-519402-12-00Estimated enrolment724 patientsSponsorCentre Hospitalier Universitaire De Toulouse

sourced from the EU Clinical Trials Register and site verification

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