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Study Comparing Antibiotic Treatment with Placebo for Patients with Acute Appendicitis Using Ertapenem, Metronidazole, and Levofloxacin

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 clinical trial is focused on studying the treatment of acute uncomplicated appendicitis, a condition where the appendix becomes inflamed but has not yet burst or caused severe complications. The study aims to compare the effectiveness of antibiotic therapy with a placebo in treating this condition. The antibiotics being tested include ertapenem, which is given as a solution through an IV infusion, and two oral tablets, metronidazole and levofloxacin. These medications are commonly used to fight infections caused by bacteria.

The purpose of the study is to determine whether antibiotics can successfully treat acute uncomplicated appendicitis without the need for surgery. Participants in the study will be randomly assigned to receive either the antibiotics or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the antibiotics and who is receiving the placebo. This helps ensure that the results are not influenced by expectations about the treatment.

Throughout the study, participants will be monitored to see if the treatment successfully resolves the appendicitis, allowing them to be discharged from the hospital without needing surgery. The study will also track any complications, the length of hospital stays, and the overall quality of life of participants over time. Follow-up evaluations will occur at various intervals, including one, three, five, and ten years after treatment, to assess any long-term effects or recurrence of appendicitis.

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 assessment

    Upon joining the study, the patient undergoes an initial assessment to confirm eligibility. This includes signing an informed consent form, being between the ages of 18 and 60, and having a CT scan that confirms a diagnosis of uncomplicated acute appendicitis.

  2. Step 2

    Randomization

    The patient is randomly assigned to receive either antibiotic therapy or a placebo. This process is double-blind, meaning neither the patient nor the healthcare providers know which treatment is being administered.

  3. Step 3

    Treatment administration

    If assigned to the antibiotic group, the patient receives ertapenem through an intravenous (IV) infusion. Additionally, metronidazole and levofloxacin are administered orally. The exact dosage and frequency are determined by the study protocol and are administered under medical supervision.

    If assigned to the placebo group, the patient receives a placebo that is indistinguishable from the actual medications, ensuring the study remains blinded.

  4. Step 4

    Monitoring and evaluation

    The patient is monitored for the resolution of appendicitis symptoms. The primary goal is to achieve discharge from the hospital without the need for surgical intervention. This is evaluated ten days after the start of the treatment.

    Secondary evaluations include monitoring for any complications, recurrence of appendicitis, duration of hospital stay, pain levels, quality of life, sick leave, and treatment costs. Follow-ups are conducted at one, three, five, and ten years.

  5. Step 5

    Follow-up

    Long-term follow-up is conducted to assess the recurrence of appendicitis and overall health outcomes. This includes periodic evaluations over a span of up to ten years.

Who can join the trial?

3 criteria

  • The patient must provide a signed document that shows they understand the study and agree to participate. This is called informed consent.
  • The patient must be between the ages of 18 and 60 years old.
  • The patient must have a diagnosis of uncomplicated acute appendicitis, which means a sudden inflammation of the appendix that is not severe or complicated. This diagnosis must be confirmed by a CT scan, which is a special type of X-ray that gives detailed pictures of the inside of the body.

Who cannot join the trial?

3 criteria

  • Patients with a different type of appendicitis that is not uncomplicated acute appendicitis cannot participate. This means if the appendicitis has complications or is not acute, the patient is excluded.
  • Patients who are younger than 3 years old cannot participate in the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not included in the study.
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Investigated drugs

Antibiotic Therapy is used in this trial to treat uncomplicated acute appendicitis. The goal is to see if antibiotics can effectively resolve the condition without the need for surgery. Antibiotics work by killing or stopping the growth of bacteria that may be causing the infection in the appendix. This approach is being compared to a placebo to determine its effectiveness in treating appendicitis.

What is already known about the treatment

Antibiotic Therapy – This treatment is administered orally or intravenously, depending on the specific antibiotic used. It is currently being studied in clinical trials to determine its effectiveness in treating uncomplicated acute appendicitis. The main therapeutic indication is to resolve inflammation and infection associated with appendicitis without the need for surgical intervention. Antibiotics work by targeting and killing bacteria or inhibiting their growth, thereby reducing infection and inflammation. They are classified as antimicrobial agents, specifically designed to combat bacterial infections.

Investigated diseases

Uncomplicated Acute Appendicitis – This condition involves inflammation of the appendix, a small pouch attached to the large intestine. It is termed "uncomplicated" when the inflammation has not led to rupture or abscess formation. Symptoms typically include sudden pain that begins around the navel and shifts to the lower right abdomen, along with nausea, vomiting, and fever. The pain often worsens with movement, coughing, or sneezing. If untreated, the inflammation can progress, but in uncomplicated cases, it remains localized without severe complications. The condition is usually diagnosed based on clinical symptoms and may require medical intervention to prevent progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520761-44-00Estimated enrolment72 patientsSponsorTurku University Hospital

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).