Study on Moxifloxacin for Treating Uncomplicated Acute Appendicitis in Adults

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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 has not yet burst or caused severe complications. The study aims to determine if antibiotics can be omitted in treating this condition. Participants will receive either an oral antibiotic called moxifloxacin or a placebo. Moxifloxacin is a type of antibiotic that is commonly used to treat bacterial infections.

The purpose of the study is to compare the effectiveness of the antibiotic treatment with a placebo in managing uncomplicated acute appendicitis. Participants will be randomly assigned to one of the two groups and will not know which treatment they are receiving to ensure unbiased results. The study will monitor the participants over a period of 30 days to see if the appendicitis resolves without the need for surgery, known as an appendectomy.

Throughout the study, researchers will also observe any complications that may arise after the treatment, the length of hospital stays, and any readmissions to the hospital. Additionally, they will assess the participants’ pain levels, quality of life, and any costs associated with the treatment. The study will help determine if antibiotics are necessary for treating uncomplicated acute appendicitis or if they can be safely omitted.

1 joining the study

Participation begins after signing an informed consent form, confirming understanding and agreement to participate in the study.

Eligibility is determined by age (18-60 years) and a CT scan confirming uncomplicated acute appendicitis.

2 randomization and treatment allocation

Participants are randomly assigned to receive either the antibiotic treatment or a placebo.

The antibiotic treatment consists of a 400 mg tablet of moxifloxacin, taken orally. The tablet is encapsulated to maintain blinding.

3 treatment administration

The assigned treatment (either moxifloxacin or placebo) is administered once daily.

The duration of the treatment is determined by the study protocol and monitored by the research team.

4 monitoring and follow-up

Participants are monitored for 30 days to assess the resolution of acute appendicitis without the need for surgery.

Regular follow-up visits are scheduled to evaluate health status, pain levels, and any complications.

5 evaluation of outcomes

The primary outcome is the success of the treatment within 30 days, defined as discharge from the hospital without surgery.

Secondary outcomes include any complications, recurrence of appendicitis, hospital stay duration, and quality of life assessments.

Who Can Join the Study?

The patient must provide a signed informed consent, which means they agree to participate in the study after understanding what it involves.
The patient must be between the ages of 18 and 60 years old.
The patient must have a diagnosis of uncomplicated acute appendicitis 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.

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 is more severe or has complications, they are not eligible.
Patients who are younger than 3 years old cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, 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
Tampere University Hospital	Tampere	Finland
Turku University Hospital	Turku	Finland
Oulu University Hospital	Oulu	Finland
Central Finland Hospital District Central Finland Hospital Nova	Jyvaskyla	Finland
Lzfec Cjrhjag Hvsgvesi	Lahti	Finland
Sdyuozpce Cetnici Hwsabpic	Seinajoki	Finland
Mgokpii Clsfdon Hnsatnyk	Mikkeli	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	15.09.2023

Trial locations

Investigated drugs:

Moxifloxacin

Oral Antibiotic Therapy is being tested in this clinical trial to see if it can effectively treat uncomplicated acute appendicitis without the need for surgery. The goal is to determine if antibiotics alone can be a safe and effective treatment option for patients with this condition.

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. The condition is usually diagnosed based on clinical symptoms and may require further observation to ensure it does not become complicated.

Trial ID:

2023-506213-21-00

Protocol code:

APPAC IV

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Moxifloxacin for Treating Uncomplicated Acute Appendicitis in Adults

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?