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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

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
Oulu University Hospital	Oulu	Finland
Turku University Hospital	Turku	Finland
Pirkanmaan hyvinvointialue	Tampere	Finland
Hjmxuhzy Uacfazyoju Ceplces Hbpwypvg	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	01.05.2017

Trial locations

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.

Investigated diseases:

Appendicitis

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 ID:

2025-520761-44-00

NCT ID:

NCT03234296

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?