AuthorisedTherapeutic use (Phase IV)Interventional

Oral Antibiotic Outpatient Therapy vs. Placebo in the Treatment of Uncomplicated Acute Appendicitis: a Randomized Double-blind Placebo-controlled Noninferiority Trial APPAC IV

This research, called APPAC IV, is investigating if antibiotics can be a good treatment for uncomplicated acute appendicitis, a mild form of appendicitis, in adults, potentially avoiding the need for surgery. Participants will be randomly given either a common antibiotic called moxifloxacin (a 400 mg tablet) or a matching dummy capsule (placebo) that contains no active medicine. This is a "double-blind" study, meaning neither the patient nor their doctor will know who is receiving the antibiotic and who is receiving the placebo. The main goal is to see if taking the antibiotic successfully treats the appendicitis within 30 days without needing an operation. Researchers will also look at whether patients experience any complications, how long they stay in hospital, their pain levels, and their quality of life. This study is for people aged 18 and over.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Turku University Hospital

Enrolment target

498

Start

23 Oct 2023

Uncomplicated acute appendicitis

What is this study about?

This study, known as APPAC IV, is investigating a new approach to treating a type of appendicitis called 'uncomplicated acute appendicitis'. This is when the appendix is inflamed but hasn't burst or caused other serious problems. Currently, the usual treatment for appendicitis is an operation to remove the appendix. However, doctors want to find out if taking antibiotics could be a safe and effective way to treat this milder form of appendicitis without surgery.

In this study, some patients will receive an antibiotic called moxifloxacin, which is a medicine used to fight bacterial infections. To make sure the study results are fair, other patients will receive a 'placebo', which looks exactly like the antibiotic but contains no active medicine. Neither you nor your doctor will know whether you're taking the antibiotic or the placebo – this is called a 'double-blind' study. This helps prevent anyone's expectations from influencing the results.

The main aim is to see if the appendicitis completely goes away within 30 days without surgery. The research team will also be closely monitoring other important things, like any health problems that might come up, how long people stay in hospital, their pain levels, and changes to their overall well-being and quality of life. The findings from this study could help doctors decide if antibiotics can be a good alternative to surgery for some patients with appendicitis.

Key takeaways

The study aims to see if antibiotics can treat mild appendicitis without surgery.
Participants will receive either an antibiotic (moxifloxacin) or a placebo (dummy pill).
It's a 'double-blind' study, so no one knows who gets which treatment at the time.
The main goal is successful treatment of appendicitis without surgery within 30 days.
This research could offer a new way to treat some cases of appendicitis.
You must be 18 or over to take part.

Who may be eligible?

This study is looking for adults who have been diagnosed with uncomplicated acute appendicitis. This means that your appendix is inflamed, but your doctors believe it's a milder form that hasn't burst or caused other major issues.

To be considered for this study, you must be at least 18 years old. Both men and women are welcome to take part. There isn't an upper age limit mentioned, so if you're an adult, you could be eligible.

Your doctors will carefully check your medical history and current health to make sure this study is right for you. They will explain if there are any specific health conditions that would prevent you from joining.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been diagnosed with uncomplicated acute appendicitis?
Are your doctors confident that your appendicitis is mild and hasn't led to serious complications?
Are you able to take medicines by mouth?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given either the antibiotic moxifloxacin or a dummy pill (placebo) in a capsule form. Both look identical, and neither you nor your doctors will know which one you are taking until after the study is complete. You will take these pills by mouth. The main part of the study involves monitoring your health for 30 days to see if your appendicitis gets better without surgery. During this time, the medical team will keep a close eye on your condition.

Beyond the initial 30 days, researchers will also check in on you for any longer-term effects or if your appendicitis comes back later. This is a 'Phase IV' study, which means it's looking at how a treatment works in real-world use after it's already been approved for other conditions. You will have regular contact with the study team for assessments, which might involve answering questions about your pain, how you're feeling, and your overall quality of life. The exact number of visits and phone calls will be explained to you by the study team, but they will be designed to monitor your progress and well-being. The total duration of your participation, including follow-up, will be made clear to you before you agree to join.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. A potential benefit of this study is that you might be able to avoid an operation for your appendicitis if the antibiotic treatment is successful for you. You would also be contributing to important medical research that could help future patients. However, there are potential risks, such as side effects from the moxifloxacin antibiotic (like stomach upset or allergic reactions), or the possibility that the antibiotic treatment might not work, meaning you would still need surgery. If you receive the placebo, your appendicitis might not improve, also leading to the need for surgery. The study team will closely monitor you for any problems. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland

Common questions

What is uncomplicated acute appendicitis?

It's a milder form of appendicitis where the appendix is inflamed but hasn't burst or caused other serious health issues.

What is moxifloxacin?

It's an antibiotic, a type of medicine used to treat bacterial infections.

What does 'double-blind' mean?

It means that neither you nor your doctor will know if you're receiving the antibiotic or the dummy pill (placebo) until after the study.

Will I still need surgery if the antibiotic doesn't work?

Yes, if the antibiotic treatment isn't successful, or if you receive the placebo and your appendicitis doesn't improve, you would still have an operation.

How long will I be followed up after the main treatment?

Researchers will check for long-term effects and if the appendicitis returns after the initial 30 days, for a period that will be explained to you.