Observing Kawasaki disease in European and North Indian children
Official title: Comparison and Performance of Kobayashi and Kawanet IVIg Resistance Scores in a Multi-centric European and North Indian Cohort of KaWasaki dIsease (the KIWI Study)
Run by Meyer Children's Hospital IRCCS · NCT06305611 · Data updated 2026-11-12
This study looks at children with Kawasaki disease to see if certain scoring systems can help identify those who don't respond to standard treatment, focusing on kids from Europe and North India.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Year to 17 Years |
| Sex | All |
| Enrollment | 103 (estimated) |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 27 sites (Rio de Janeiro and 26 other locations) |
| Status | Recruiting |
| Started | July 13, 2021 |
| Main results expected | July 15, 2026 |
| Study ends | October 30, 2026 |
| Registry record updated | September 29, 2025 |
| Trial ID | NCT06305611 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children under 18 years old who have been diagnosed with Kawasaki disease according to the American Heart Association criteria.
✕Probably not a fit
Patients who do not meet the criteria for Kawasaki disease or have alternative infectious diagnoses may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on Kawasaki disease (KD), which is a leading cause of acquired heart disease in children. It aims to identify patients who are resistant to standard treatment with intravenous immunoglobulin (IVIG) by utilizing scoring systems developed in previous studies. The study will assess the effectiveness of these scoring systems in predicting treatment resistance across different ethnic populations, particularly in European and North Indian cohorts. By understanding the variations in treatment response, the study seeks to improve initial therapy strategies for KD patients.
Why it matters
Potential benefit: If successful, this study could lead to better identification of Kawasaki disease patients who require more aggressive treatment, potentially reducing the risk of serious cardiac complications.
How similar studies have gone: Previous studies have shown varying success with similar scoring systems in predicting treatment resistance, but their effectiveness in diverse ethnic populations remains to be confirmed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged less than 18 years at diagnosis * Diagnosis of KD according to the AHA criteria Exclusion Criteria: * Patients who do not meet the criteria for KD * Patients for which an alternative infectious diagnosis was not investigated and/or excluded.
Where it's running
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Universidade Federal do Rio de Janeiro
Rio de Janeiro, Brazil Recruiting -
Children's Hospital Zagreb
Zagreb, Croatia Recruiting -
University Hospital Centre Zagreb, University School of Medicine
Zagreb, Croatia Recruiting -
Postgraduate Institute of Medical Education and Research
Chandigarh, India Recruiting -
Institute of Child Health
Kolkata, India Recruiting -
ASST Papa Giovanni XXIII
Bergamo, Italy Recruiting
Show 21 more locations
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Spedali Civili
Brescia, Italy Recruiting -
Meyer Children's Hospital IRCCS
Florence, Italy Recruiting -
IRCCS Istituto Giannina Gaslini
Genova, Italy Recruiting -
Università di Torino
Torino, Italy Recruiting -
IRCCS Burlo Garofolo
Trieste, Italy Recruiting -
Hospital de Sabadell
Barcelona, Spain Recruiting -
Hospital Sant Joan de Déu
Barcelona, Spain Recruiting -
Chiang Mai University Hospital
Chiang Mai, Thailand Recruiting -
Hacettepe University Children's Hospital
Ankara, Turkey (Türkiye) Recruiting -
Health Sciences University, Umraniye Education and Research Hospital
Istanbul, Turkey (Türkiye) Recruiting -
Royal Hospital for Children
Bristol, United Kingdom Recruiting -
Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI
Le Kremlin-Bicêtre, France Not yet recruiting -
Manipal Hospital
Bangalore, India Not yet recruiting -
Sri Ramachandra Medical Centre
Chennai, India Not yet recruiting -
Amrita Institute of Medical Sciences
Kochi, India Not yet recruiting -
Vivekananda Institute of Medical Sciences
Kolkata, India Not yet recruiting -
Meir Medical Centre
Kfar Saba, Israel Not yet recruiting -
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico
Milan, Italy Not yet recruiting -
P.O. "Giovanni Di Cristina"
Palermo, Italy Not yet recruiting -
Beatrix Kinderkliniek, University Medical Center
Groningen, Netherlands Not yet recruiting -
Istanbul Uni. Istanbul Med.Fac
Istanbul, Turkey (Türkiye) Not yet recruiting
Study contacts
- Study coordinator: Gabriele Simonini
- Email: gabriele.simonini@meyer.it
- Phone: 3297973141
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Atorvastatin in Chinese children with Kawasaki disease and coronary artery abnormalities
This phase 3 study tests whether atorvastatin is safe and helpful for children with Kawasaki disease who have coronary artery abnormalities.
-
Kawasaki MATCH decision support for suspected Kawasaki disease
This study will test a machine-learning tool called Kawasaki MATCH to help providers decide if febrile children might have Kawasaki disease.
-
Cardiovascular health in children and young adults with chronic conditions
This project will see if children and young adults (ages 6-25) with chronic health conditions show early signs of aging in large and small blood vessels using noninvasive imaging and clinical tests.
-
Analyzing Rivaroxaban in Chinese Children with Kawasaki Disease
This study is testing how well the blood thinner rivaroxaban works in children with Kawasaki disease who have serious heart problems.
-
Optimizing Rivaroxaban Dosing for Children with Giant Coronary Aneurysms After Kawasaki Disease
This study is testing a new way to dose a blood thinner called rivaroxaban for Chinese children with giant coronary aneurysms after Kawasaki disease to see if it helps prevent heart problems.
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Rivaroxaban for children over 2 with giant coronary artery aneurysms after Kawasaki disease
This trial will test whether rivaroxaban given with an antiplatelet medicine is a safe and practical alternative to warfarin for preventing clots in children aged 2 and older with giant coronary artery aneurysms after Kawasaki disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.