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AuthorisedTherapeutic use (Phase IV)Interventional

Clinical and economical efficiency and safety and inflammation parameter correlations study of conservative treatment of non-complicated acute appendicitis in 7 to 18 years old children.

This study is for children and teenagers aged 7 to 18 who have a mild form of appendicitis that has not caused any major problems. Researchers want to find out how well and how safely a treatment with antibiotics works for this condition, compared to other usual care. The study will also look at how these antibiotics affect swelling in the body. The aim is to see if treating appendicitis with antibiotics can be a good option, possibly avoiding surgery for some young people. Participants will receive antibiotics and be carefully monitored. The study will track their health for a short time in the hospital and then at home, with follow-up checks after one month and one year to see how they are doing in the long term. This is an important step to improve how we care for children with appendicitis.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Riga Stradins University
Enrolment target
60
Start
30 Jan 2025

What is this study about?

This study is looking at a condition called 'acute non-complicated appendicitis' in young people aged 7 to 18. Appendicitis is when your appendix, a small finger-shaped organ, becomes swollen. 'Acute' means it comes on suddenly, and 'non-complicated' means it's a milder form where the appendix hasn't burst or caused other serious problems.

Traditionally, surgery has been the main way to treat appendicitis. However, doctors are now exploring if strong antibiotics could be a safe and effective treatment for this milder type of appendicitis, potentially helping children avoid an operation. This study wants to understand how well antibiotic treatment works, if it's safe, and how it affects the swelling in the body.

Learning more about treating appendicitis with antibiotics is important because if it's a good option, it could mean fewer children need surgery, which can lead to a quicker recovery and less time in hospital. This study is taking place after the main testing phases of these medicines, meaning the antibiotics are already approved for use, and this research helps us understand their use specifically for appendicitis in young people.

Key takeaways

  • Targets children aged 7-18 with mild appendicitis.
  • Investigates antibiotics as an alternative to surgery.
  • Involves 3 days in hospital, followed by 7 days at home.
  • Includes follow-up checks at 1 month and 1 year.
  • Aims to improve treatments for appendicitis in young people.

Who may be eligible?

This study is looking for young people aged between 7 and 18 years old. Both boys and girls can take part in this research.

To be included, they must have a diagnosis of 'acute non-complicated appendicitis'. This means they have a sudden onset of appendicitis, but it's a milder form where the appendix hasn't burst or caused any major problems yet.

The research team will carry out some checks to make sure that each young person meets all the requirements to safely take part in the study.

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. Is your child between 7 and 18 years old?
  2. Has your child been diagnosed with 'acute non-complicated appendicitis'?
  3. Has the doctor confirmed the appendicitis is mild and hasn't caused major problems?
  4. Are you comfortable with your child receiving antibiotics as a primary treatment?
Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they would typically stay in the hospital for about 3 days. During this time, they would receive antibiotics, likely through a drip at first, and be closely monitored by doctors and nurses.

After leaving the hospital, the antibiotic treatment would continue at home for another 7 days. This might involve taking antibiotic tablets. The medical team would provide clear instructions on how to continue the treatment at home.

After the initial treatment, there will be follow-up appointments. Your child will be checked again one month later, and then again after one year. These checks are to make sure they have recovered well and to see how they are doing in the long term. The total duration of active follow-up for the study is one year.

Potential risks and benefits

Taking part in this study might offer a potential benefit of treating appendicitis with antibiotics, possibly avoiding surgery and its associated risks. However, like all medicines, antibiotics can have side effects, such as upset stomachs or allergic reactions. The research team will carefully monitor your child for any side effects and provide appropriate care. There is also a small chance that the antibiotic treatment might not work, and your child might still need surgery. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

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

Common questions

What is 'non-complicated appendicitis'?

This is a milder form of appendicitis where the appendix is swollen but hasn't burst or caused other major issues.

Will my child need surgery if they join this study?

One aim of this study is to see if antibiotics can help children avoid surgery for non-complicated appendicitis. However, some children might still need surgery if the antibiotics don't work or if their condition changes.

What kind of antibiotics will be used?

The study involves several types of antibiotics, including ones like Amoxicillin-Clavulanic Acid and Metronidazole, which are commonly used for infections.

How long will my child be in hospital?

Children typically stay in the hospital for about 3 days for initial treatment and monitoring.

Are there follow-up appointments?

Yes, there will be check-ups one month and one year after treatment to ensure your child has recovered well.

How to find out more

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

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