Clinical trial Recruiting at 17 sites Observational Ages 1 Year to 17

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.

More Kawasaki Disease trials

Quick facts

Study typeObservational
Ages1 Year to 17 Years
SexAll
Enrollment103 (estimated)
SponsorMeyer Children's Hospital IRCCS
Academic / other
Locations27 sites (Rio de Janeiro and 26 other locations)
StatusRecruiting
StartedJuly 13, 2021
Main results expectedJuly 15, 2026
Study endsOctober 30, 2026
Registry record updatedSeptember 29, 2025
Trial IDNCT06305611 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.