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European and North Indian Cohort of KaWasaki dIsease

This study, called 'KaWasaki dIsease', is looking into Kawasaki disease in children and young people across Europe and North India. Kawasaki disease is a serious illness that can affect a child’s heart. While standard treatments usually work well, some children don't respond, putting them at higher risk of heart problems like aneurysms. Researchers are testing different scoring systems that aim to identify these children early on so they can get more effective treatment right away. The main goal is to find out if these scoring systems, which have worked in some populations, also work well for children with Kawasaki disease in other parts of the world, helping to prevent long-term heart issues.

At a glance

Status
Recruiting
Sponsor
Meyer Children's Hospital IRCCS
Enrolment target
103
Start
13 Jul 2021
Estimated completion
30 Oct 2026

What is this study about?

This study, known as the 'European and North Indian Cohort of KaWasaki dIsease' study, is focused on improving how we treat a serious childhood illness called Kawasaki disease (KD). KD is the most common cause of heart problems that children can develop during their lives. It's really important to treat KD quickly and effectively because it can sometimes damage the tiny blood vessels that supply the heart, called coronary arteries. If these arteries get damaged, they could widen abnormally (a problem called a coronary aneurysm), which can lead to serious heart issues later on, including heart attacks or, very rarely, sudden death.

Most children with Kawasaki disease respond well to the usual treatment, which has significantly reduced the number of children who develop heart damage. However, about 10 to 20 out of every 100 children don't respond to this standard treatment. These children are at a much higher risk of developing serious, long-term heart problems. That's why doctors are very keen to find ways to predict early on which children might not respond to the usual treatment, so they can offer stronger medicine from the start.

Over the years, different tools, or 'scoring systems', have been developed to try and identify these children. Some of these tools have shown promise in specific groups of children, for example, in Japan. However, they haven't always worked as well in children from different backgrounds or parts of the world. This study is testing some of these scoring systems to see if they can accurately predict treatment resistance in children with Kawasaki disease in Europe and North India. If these tools prove to be reliable, it could lead to earlier and more effective treatment for children who need it most, ultimately helping to protect their hearts.

Key takeaways

  • Kawasaki disease is a serious childhood illness affecting the heart.
  • The study aims to improve prediction of treatment resistance in children with Kawasaki disease.
  • Better prediction could lead to earlier and more effective treatment options.
  • It aims to validate existing scoring systems in Europe and North India.
  • Participation involves reviewing existing medical records, not new treatments or visits.

Who may be eligible?

To be part of this study, a child needs to be under 18 years old when they are diagnosed with Kawasaki disease. Importantly, their doctor must have diagnosed Kawasaki disease using specific guidelines provided by the American Heart Association (AHA).

Children will not be able to join the study if their doctors don't believe they have Kawasaki disease, or if there's a strong chance another infection is causing their illness and this hasn't been properly checked out or ruled out by a doctor. The study is open to both boys and girls.

The age range for participants is from 1 year old up to 17 years old at the time of their Kawasaki disease diagnosis.

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. My child was diagnosed with Kawasaki disease.
  2. My child was under 18 years old at the time of diagnosis.
  3. A doctor confirmed the Kawasaki disease diagnosis using standard criteria.
  4. My child's doctors have ruled out other infections as the cause of their illness.
Answer every question to see your result.

What does participation involve?

The study aims to gather information from children diagnosed with Kawasaki disease. This means that if you or your child are taking part, their medical records, including information about their diagnosis, treatment, and how they responded, will be collected by the research team. You likely won't need to attend extra visits or take new medications specifically for this study. The researchers will be looking at existing medical information to help them understand if the scoring systems work. The total duration of participation will depend on how long the researchers need to follow up on the child's health information.

Potential risks and benefits

Potential benefits of participating in this study include contributing to a better understanding of Kawasaki disease, which could lead to improved diagnosis and treatment for future children. There are no direct medical benefits for individual participants as the study is reviewing existing data and does not involve new treatments or procedures. Since the study primarily involves collecting and analysing existing medical information, there are very few direct risks to participants. Any information collected will be kept private and anonymised where possible. You always have the right to withdraw your consent for your child's data to be used in the study at any time, without it affecting their medical care.

Locations (27)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Universidade Federal do Rio de Janeiro
    Verified postcode
    Rio de Janeiro, Brazil· Recruiting
  • Children's Hospital Zagreb
    Verified postcode
    Zagreb, Croatia· Recruiting
  • University Hospital Centre Zagreb, University School of Medicine
    Verified postcode
    Zagreb, Croatia· Recruiting
  • Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI
    Verified postcode
    Le Kremlin-Bicêtre, France· Not yet recruiting
  • Manipal Hospital
    Verified postcode
    Bangalore, India· Not yet recruiting
  • Postgraduate Institute of Medical Education and Research
    Verified postcode
    Chandigarh, India· Recruiting
  • Sri Ramachandra Medical Centre
    Verified postcode
    Chennai, India· Not yet recruiting
  • Amrita Institute of Medical Sciences
    Verified postcode
    Kochi, India· Not yet recruiting
  • Institute of Child Health
    Verified postcode
    Kolkata, India· Recruiting
  • Vivekananda Institute of Medical Sciences
    Verified postcode
    Kolkata, India· Not yet recruiting
  • Meir Medical Centre
    Verified postcode
    Kfar Saba, Israel· Not yet recruiting
  • ASST Papa Giovanni XXIII
    Verified postcode
    Bergamo, Italy· Recruiting

Common questions

What is Kawasaki disease?

Kawasaki disease is a serious illness that mainly affects young children. It causes inflammation in blood vessels throughout the body, especially those leading to the heart.

What is 'standard treatment' for Kawasaki disease?

The usual treatment for Kawasaki disease often involves giving a medicine called intravenous immunoglobulin (IVIG), which helps to reduce inflammation.

Why is this study important for children who don't respond to treatment?

Some children don't respond to the usual treatment, which can put their hearts at higher risk. This study tries to find better ways to identify these children early so they can get more suitable treatment.

Will my child have to take new medicine or have extra appointments?

No, this study mainly reviews existing medical records. Your child won't need new medicines or extra appointments specifically for this research.

What happens if my child is in the study?

Researchers will gather information from your child's medical notes about their Kawasaki disease diagnosis, treatment, and recovery to help them understand the illness better.

How to find out more

Gabriele Simonini

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

Interested in taking part?

Register your interest

Share your details and the research team for "European and North Indian Cohort of KaWasaki dIsease…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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