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Study on the Effects of Moxifloxacin and Drug Combination for Patients with Acute Appendicitis

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What is this trial about?

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

This clinical trial focuses on studying acute appendicitis, which is a condition where the appendix becomes inflamed and painful. The study includes both uncomplicated and complicated forms of this condition. The purpose of the study is to understand the causes of acute appendicitis and to examine how different treatments affect the bacteria in the gut, known as the microbiota. The study will also look at how the length of hospital stay might influence the bacteria in the gut.

Participants in the study will receive one of several antimicrobial treatments. These treatments include levofloxacin, which is taken as a tablet, ertapenem, which is given as a solution for infusion, metronidazole, which is also taken as a tablet, and moxifloxacin, which is provided as a film-coated tablet. These medications are used to help fight infections and are part of the study to see how they impact the gut microbiota.

The study will follow participants over a period of time to observe changes in the gut microbiota and to determine if there is any connection between these changes and the severity of appendicitis. Participants will be monitored for the duration of their treatment, which varies depending on the medication, and the effects on their gut bacteria will be evaluated. The study aims to provide insights into the relationship between antimicrobial treatments and gut health in patients with acute 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

    Joining the study

    Upon joining the study, the patient must provide a signed informed consent.

    Eligibility requires the patient to be between 18 and 60 years old and have a CT scan confirming a diagnosis of either uncomplicated or complicated acute appendicitis.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the diagnosis and determine the appropriate treatment plan.

    The assessment includes a review of medical history and current health status.

  3. Step 3

    Treatment phase

    The treatment involves the administration of antimicrobial medications.

    The medications used include levofloxacin, ertapenem, metronidazole, and moxifloxacin.

    Levofloxacin is administered orally.

    Ertapenem is administered through an intravenous (IV) infusion.

    Metronidazole and moxifloxacin are administered orally.

    The specific dosage, frequency, and duration of each medication are determined based on the patient's condition and response to treatment.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to evaluate the patient's response to treatment and any changes in gut microbiota.

    Follow-up appointments are scheduled to assess recovery and any potential side effects of the treatment.

  5. Step 5

    Study endpoint

    The primary endpoint of the study is to evaluate changes in gut microbiota species variation.

    The study aims to determine any correlation between gut microbiota and complicated appendicitis by comparing species variation.

Who can join the trial?

3 criteria

  • You must have signed an informed consent form. This means you agree to participate in the study after understanding what it involves.
  • You need to be between 18 and 60 years old.
  • You must have a CT scan that confirms you have either uncomplicated acute appendicitis or complicated acute appendicitis. Complicated appendicitis may include conditions like an appendicolith (a stone in the appendix), perforation (a hole in the appendix), an abscess (a collection of pus), or a suspicion of a tumor (an abnormal growth).

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients who have allergies to the medications used in the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had recent surgery that could affect the study results.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have a mental health condition that could affect their ability to participate.
  • Patients who have a known infection that could interfere with the study.
  • Patients who have been diagnosed with a chronic illness that is not stable.
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Investigated drugs

Antimicrobial Treatment is used in this study to treat acute appendicitis. The goal is to understand how this treatment affects the gut microbiota, which is the community of microorganisms living in the intestines. The study aims to see how the antimicrobial treatment changes the balance of these microorganisms and how it might influence the development of antibiotic resistance.

What is already known about the treatment

Amoxicillin – Amoxicillin is an antibiotic administered orally, typically in the form of tablets or liquid suspension. It is widely used in medicine to treat various bacterial infections, including uncomplicated and complicated acute appendicitis. The medication works by inhibiting the synthesis of bacterial cell walls, effectively killing the bacteria. Amoxicillin belongs to the class of drugs known as penicillins, which are part of the broader group of beta-lactam antibiotics.

Investigated diseases

  • Uncomplicated Acute Appendicitis

    This condition involves inflammation of the appendix, a small pouch attached to the large intestine. It typically begins with pain near the belly button, which then moves to the lower right side of the abdomen. The pain may be accompanied by nausea, vomiting, and a mild fever. In uncomplicated cases, the appendix has not burst or formed an abscess. The inflammation is usually limited to the appendix itself. If not addressed, it can progress to a more severe form.

  • Complicated Acute Appendicitis

    This form of appendicitis occurs when the appendix becomes severely inflamed and may lead to rupture or the formation of an abscess. The symptoms are similar to uncomplicated appendicitis but tend to be more severe and persistent. The pain may spread throughout the abdomen, and there may be signs of infection such as a high fever. Complications arise when the inflamed appendix bursts, leading to infection in the abdominal cavity. This condition requires more intensive management to prevent further complications.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519392-26-00Estimated enrolment118 patientsSponsorTurku University Hospital

sourced from the EU Clinical Trials Register and site verification

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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).