Study on Antibiotic Treatment for Uncomplicated Acute Appendicitis Using Levofloxacin, Ertapenem, and Moxifloxacin in Adult Patients

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What is this study about?

This clinical trial is focused on studying the treatment of uncomplicated acute appendicitis, a condition where the appendix becomes inflamed but does not have severe complications. The study aims to compare two different approaches to treating this condition using antibiotics. One approach involves taking antibiotics by mouth, known as oral antibiotics, while the other involves starting with antibiotics given through a vein, known as intravenous antibiotics, followed by oral antibiotics.

The antibiotics being studied in this trial include Levofloxacin, Ertapenem, Moxifloxacin, and Metronidazole. Levofloxacin and Moxifloxacin are taken as tablets, while Ertapenem is given as a solution through an infusion, which is a method of delivering medication directly into the bloodstream. Metronidazole is also taken as a tablet. These medications are all antimicrobial agents, which means they are used to treat infections caused by bacteria.

The purpose of the study is to determine if oral antibiotic treatment alone is as effective as the combination of intravenous and oral antibiotics in treating uncomplicated acute appendicitis. Participants in the study will receive one of these treatments, and their progress will be monitored to see if the appendicitis resolves without the need for surgery and does not return within a year. The study will also look at other factors such as any complications after treatment, the length of hospital stay, and the overall quality of life of the participants during the follow-up period.

1 joining the study

Participation begins after meeting the inclusion criteria: age between 18 and 60 years, and a diagnosis of uncomplicated acute appendicitis confirmed by a CT scan.

The CT scan must show an appendiceal diameter over 6 mm with a thickened and enhancing wall, periappendiceal edema, or minor fluid collection, without signs of complicated appendicitis.

2 randomization and treatment allocation

Participants are randomly assigned to one of two treatment groups: oral antibiotic monotherapy or a combination of intravenous and oral antibiotics.

3 oral antibiotic monotherapy

Participants in this group receive levofloxacin and metronidazole orally.

The specific dosage and frequency are determined by the study protocol.

4 intravenous and oral antibiotic therapy

Participants in this group initially receive ertapenem through an intravenous infusion.

After the intravenous treatment, participants switch to oral antibiotics, specifically moxifloxacin and metronidazole.

The duration and dosage are specified in the study protocol.

5 follow-up and monitoring

Participants are monitored for treatment success, defined as the resolution of appendicitis without surgery and no recurrence within one year.

Follow-up includes assessing any complications, recurrence of appendicitis, hospital stay duration, pain levels, quality of life, sick leave length, and treatment costs.

6 completion of the study

The study concludes with a one-year follow-up to evaluate the primary endpoint of treatment success.

Secondary endpoints such as complications, recurrence, and quality of life are also assessed.

Who Can Join the Study?

  • Must be between the ages of 18 and 60 years old.
  • Must have a diagnosis of uncomplicated acute appendicitis. This means the appendix is swollen and inflamed but not severely damaged or ruptured.
  • The diagnosis must be confirmed by a CT scan. A CT scan is a special type of X-ray that gives detailed pictures of the inside of the body.
  • The CT scan must show that the appendix is larger than 6 millimeters, has a thickened wall, and there is some swelling or minor fluid around it.
  • There should be no signs of complicated appendicitis, which would mean more severe issues like a burst appendix.
  • Both men and women can participate.
  • Participants should not be part of a vulnerable population, meaning they should be able to make decisions for themselves and not be in a situation where they are easily influenced or at risk.

Who Cannot Join the Study?

  • Patients with a condition other than uncomplicated acute appendicitis cannot participate. This means if the appendicitis is more severe or has complications, they are not eligible.
  • Patients who are younger than 18 years old cannot participate. The study is only for adults.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or have certain disabilities, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Kuopio University Hospital Kuopio Finland

Other Sites

Site Name City Country Status
Oulu University Hospital Oulu Finland
Central Finland Hospital District Central Finland Hospital Nova Jyvaskyla Finland
Turku University Hospital Turku Finland
Pirkanmaan hyvinvointialue Tampere Finland
Mynmkaz Cosblod Hvdilonh Mikkeli Finland
Stgkymyrk Cdtuikg Hlyjeywr Seinajoki Finland
Ltszxpm Cgbxpxd Hceppycu Rovaniemi Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Not yet recruiting
01.04.2017

Trial locations

Amoxicillin is an antibiotic used to treat various bacterial infections. In this trial, it is used to treat uncomplicated acute appendicitis. It works by stopping the growth of bacteria.

Clavulanic Acid is often combined with amoxicillin to enhance its effectiveness. It helps prevent bacteria from becoming resistant to amoxicillin, ensuring the treatment remains effective.

Metronidazole is another antibiotic used in this trial. It is effective against certain types of bacteria and parasites. In the context of appendicitis, it helps eliminate bacteria that may not be targeted by other antibiotics.

Ciprofloxacin is an antibiotic that treats a wide range of bacterial infections. It is used in this trial to help manage uncomplicated acute appendicitis by killing bacteria or preventing their growth.

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 beginning around the navel and often shifting to the lower right abdomen, along with nausea, vomiting, and fever. The pain may increase with movement, coughing, or sneezing. If untreated, the inflammation can worsen, but in uncomplicated cases, it remains localized. The progression is usually rapid, requiring timely medical attention to prevent complications.

Trial ID:
2024-518984-36-00
NCT ID:
NCT03236961
Trial Phase:
Therapeutic confirmatory (Phase III)

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