European and North Indian Cohort of KaWasaki dIsease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Kawasaki Disease. Basic parameters: 1 year — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil, Croatia, France, India, Israel +6
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Primary outcome measures
- IVIG resistance rate [Time frame: through study completion, an average of 1 year]
- percentage of IVIG-resistant patients [Time frame: through study completion, an average of 1 year]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 8 centers
- ASST Papa Giovanni XXIII — Bergamo
- Spedali Civili — Brescia
- Meyer Children's Hospital IRCCS — Florence
- IRCCS Istituto Giannina Gaslini — Genova
- Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico — Milan
- P.O. "Giovanni Di Cristina" — Palermo
- Università di Torino — Torino
- IRCCS Burlo Garofolo — Trieste
India · 6 centers
- Manipal Hospital — Bangalore
- Postgraduate Institute of Medical Education and Research — Chandigarh
- Sri Ramachandra Medical Centre — Chennai
- Amrita Institute of Medical Sciences — Kochi
- Institute of Child Health — Kolkata
- Vivekananda Institute of Medical Sciences — Kolkata
Turkey (Türkiye) · 3 centers
- Hacettepe University Children's Hospital — Ankara
- Health Sciences University, Umraniye Education and Research Hospital — Istanbul
- Istanbul Uni. Istanbul Med.Fac — Istanbul
Croatia · 2 centers
- Children's Hospital Zagreb — Zagreb
- University Hospital Centre Zagreb, University School of Medicine — Zagreb
Spain · 2 centers
- Hospital de Sabadell — Barcelona
- Hospital Sant Joan de Déu — Barcelona
Brazil · 1 center
- Universidade Federal do Rio de Janeiro — Rio de Janeiro
France · 1 center
- Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI — Le Kremlin-Bicêtre
Israel · 1 center
- Meir Medical Centre — Kfar Saba
Netherlands · 1 center
- Beatrix Kinderkliniek, University Medical Center — Groningen
Thailand · 1 center
- Chiang Mai University Hospital — Chiang Mai
United Kingdom · 1 center
- Royal Hospital for Children — Bristol
Publications
- Mastrolia MV, Pandiarajan V, Cattalini M, Taddio A, Vergnano S, Anton J, Sontichai W, Sozeri B, Ozen S, Rosina S, Sanchez-Manubens J, Haviv R, Pal P, Fonseca AR, Gagro A, Bagri NK, Verdoni L, Montin D, Maggio MC, Thangaraj A, Pilania R, Mosquera M, Calzada J, Sittiwangkul R, Ulu K, Balik Z, Bilginer Y, Garrone M, Patrone E, Barbi E, Ciacci G, Barucci A, Ruperto N, Simonini G. Predictive value for PMID 41809203
Identifiers
NCT: NCT06305611 · KIWI