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AuthorisedTherapeutic use (Phase IV)Interventional

Optimizing the antibiotic treatment of uncomplicated acute appendicitis: a prospective randomized multicenter study

This research study is called the APPAC II trial, and it's looking into the best way to treat a common condition called uncomplicated acute appendicitis. This is when your appendix becomes inflamed but hasn't burst or caused other serious problems. The study aims to find out if certain antibiotic treatments, like LEVOFLOXACIN, ERTAPENEM, MOXIFLOXACIN, and METRONIDAZOLE, can successfully treat appendicitis without the need for surgery. Researchers will track participants for a whole year to see if the appendicitis goes away and doesn't come back. They also want to understand the overall experience, including how long people stay in hospital, their quality of life, and any potential side effects. The study is open to adults aged 18 and above.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Turku University Hospital
Enrolment target
599
Start
20 Nov 2024

What is this study about?

This study, called APPAC II, is focused on finding the best way to treat uncomplicated acute appendicitis. This is a common condition where your appendix, a small finger-shaped pouch connected to your large intestine, becomes swollen and painful. When it's 'uncomplicated,' it means the appendix hasn't ruptured or caused wider infection, which are more serious situations.

The main goal of this research is to see if antibiotic treatments can effectively clear up appendicitis and avoid the need for an operation to remove the appendix. Researchers are comparing several different antibiotics to see which ones work best. They will be checking if the treatment successfully resolves the appendicitis and if it stops it from coming back for at least a year.

Beyond simply curing the appendicitis, the study will also look at other important things. This includes how long people need to stay in hospital, any complications that might arise, how the treatment affects a person's quality of life, and even how much sick leave might be needed. By gathering all this information, doctors hope to offer better, less invasive treatment options for people with uncomplicated appendicitis in the future.

Key takeaways

  • This study evaluates antibiotic treatments for mild appendicitis.
  • The aim is to avoid surgery and prevent the appendicitis from returning.
  • Participation involves receiving antibiotics and a one-year follow-up.
  • It's for adults aged 18 and over with uncomplicated appendicitis.
  • Results will help doctors choose the best treatment for future patients.

Who may be eligible?

This study is particularly looking for adults who have been diagnosed with uncomplicated acute appendicitis. This means your appendicitis is inflamed but has not ruptured or spread, which are more serious forms of the condition.

To be considered for this study, you must be at least 18 years old. There is no upper age limit, meaning older adults can also take part.

Both men and women are welcome to participate in this research. The study aims to include a diverse group of people to ensure the results are as helpful as possible for everyone.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with uncomplicated acute appendicitis?
  3. Has a doctor told you your appendicitis hasn't ruptured or caused other serious complications?
  4. Are you able to attend follow-up appointments for up to one year?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive one of the different antibiotic treatments being tested. This means you wouldn't get to choose which specific antibiotic you receive.

The main goal is to see if your appendicitis can be successfully treated with antibiotics, allowing you to go home without needing surgery. You would be closely monitored during your hospital stay.

After you leave the hospital, the research team will follow up with you for a full year. This is to check if the appendicitis has truly gone away and if it comes back at any point. You might have check-up appointments or questionnaires to fill out to assess your health, any complications, your quality of life, and how much time you've had to take off work. The total time you'd be involved in the study's follow-up would be one year.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might be successfully treated for your appendicitis with antibiotics, helping you avoid surgery, which carries its own risks. You would also be contributing to important research that could improve treatment for others in the future. Potential risks could include side effects from the antibiotics, or the possibility that the antibiotic treatment might not work, meaning you might still need surgery later. There's also the chance of the appendicitis returning. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Common questions

What is 'uncomplicated acute appendicitis'?

It means your appendix is inflamed but hasn't burst or caused a widespread infection, which are more serious forms of the condition.

Why is this study being done?

Doctors want to find out if antibiotics can be a safe and effective treatment for appendicitis, potentially helping people avoid surgery.

Will I have surgery if I join this study?

The goal is for you to avoid surgery, but if the antibiotics don't work, surgery might still be needed. This is something the study is trying to understand.

How long will I be involved in the study?

You'll be followed up for one year after your initial treatment to see if the appendicitis returns.

Can I choose which antibiotic I get?

No, you would be randomly assigned to one of the antibiotic treatments being tested, like drawing names from a hat.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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