European and North Indian Cohort of KaWasaki dIsease
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)
1 other identifier
observational
103
11 countries
27
Brief Summary
Kawasaki disease (KD) is currently the leading cause of acquired heart diseases in children in developed countries. Cardiac involvement is the main determinant of the long-term prognosis of these patients, as coronary aneurisms (CAAs) may lead to ischemic heart disease and even sudden death. The current standard of care for KD has consistently reduced CAAs frequency from 25-30% to about 5%. Unfortunately, 10-20% of KD patients results resistant to standard treatment leading to a major risk of cardiac complications. Thus, scoring systems have been constructed in order to identify patients likely to be resistant to IVIG and who may benefit from more aggressive initial therapy. Different scoring scales developed by Kobayashi, Egami et Sano had shown a good sensitivity (77-86%) and specificity (67-86%) in predicting IVIG unresponsiveness in Japanese populations. However, their predictive value was not confirmed by subsequent studies in different ethnic populations. Recently, the French Kawanet group have proposed a IVIG unresponsiveness score that provided good sensitivity and acceptable specificity in a non-Asian KD population even if it was not subsequent validated by an external study. In our study population, the achievement of specificity and sensitivity values for both scores consistent with those reported by the original studies (sensitivity 70% and specificity 80% for Kobayashi and sensitivity 77% and specificity 60% for Kawanet), will be considered a success.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2021
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 13, 2021
CompletedFirst Submitted
Initial submission to the registry
February 16, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2026
September 29, 2025
September 1, 2025
5 years
February 16, 2024
September 23, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
IVIG resistance rate
IVIG resistance rate in patients with KD and stratification according to different ethnic groups.
through study completion, an average of 1 year
percentage of IVIG-resistant patients
percentage of IVIG-resistant patients who met the Kobayashi and KAWANET criteria, and specificity and sensitivity of the criteria within the different ethnic groups.
through study completion, an average of 1 year
Eligibility Criteria
The setting is represented by 1 Asian and 4 European pediatric rheumatology centres which with internationally recognized expertise in the treatment and follow-up of a large number of Kawasaki disease patients
You may qualify if:
- Patients aged less than 18 years at diagnosis
- Diagnosis of KD according to the AHA criteria
You may not qualify if:
- Patients who do not meet the criteria for KD
- Patients for which an alternative infectious diagnosis was not investigated and/or excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Brazil
Children's Hospital Zagreb
Zagreb, Croatia
University Hospital Centre Zagreb, University School of Medicine
Zagreb, Croatia
Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI
Le Kremlin-Bicêtre, France
Manipal Hospital
Bangalore, India
Postgraduate Institute of Medical Education and Research
Chandigarh, India
Sri Ramachandra Medical Centre
Chennai, India
Amrita Institute of Medical Sciences
Kochi, India
Institute of Child Health
Kolkata, India
Vivekananda Institute of Medical Sciences
Kolkata, India
Meir Medical Centre
Kfar Saba, Israel
ASST Papa Giovanni XXIII
Bergamo, Italy
Spedali Civili
Brescia, Italy
Meyer Children's Hospital IRCCS
Florence, Italy
IRCCS Istituto Giannina Gaslini
Genova, Italy
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico
Milan, Italy
P.O. "Giovanni Di Cristina"
Palermo, Italy
Università di Torino
Torino, Italy
IRCCS Burlo Garofolo
Trieste, Italy
Beatrix Kinderkliniek, University Medical Center
Groningen, Netherlands
Hospital de Sabadell
Barcelona, Spain
Hospital Sant Joan de Déu
Barcelona, Spain
Chiang Mai University Hospital
Chiang Mai, Thailand
Hacettepe University Children's Hospital
Ankara, Turkey (Türkiye)
Health Sciences University, Umraniye Education and Research Hospital
Istanbul, Turkey (Türkiye)
Istanbul Uni. Istanbul Med.Fac
Istanbul, Turkey (Türkiye)
Royal Hospital for Children
Bristol, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 16, 2024
First Posted
March 12, 2024
Study Start
July 13, 2021
Primary Completion (Estimated)
July 15, 2026
Study Completion (Estimated)
October 30, 2026
Last Updated
September 29, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share