Actively Recruiting

Age: 1Year - 17Years
All Genders
ID06305611

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)

Led by Meyer Children's Hospital IRCCS · Updated on 2025-09-29

103

Participants Needed

27

Research Sites

15 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Kawasaki disease (KD) is a leading cause of acquired heart disease in children, particularly in developed countries. The study evaluates the performance of two scoring systems, Kobayashi and Kawanet, which aim to predict resistance to intravenous immunoglobulin (IVIG) treatment in KD patients. Resistance to IVIG occurs in 10-20% of patients and poses a significant risk for cardiac complications like coronary aneurysms. The study focuses on a multi-center European and North Indian cohort to assess the sensitivity and specificity of these scores in non-Asian populations. This observational study does not involve experimental treatments but monitors KD patients aged 1 to 17 years diagnosed according to American Heart Association (AHA) criteria. It compares the Kobayashi and Kawanet IVIG resistance scores to determine their accuracy in predicting which patients may not respond to standard IVIG therapy. The study spans an average duration of one year during which patients are observed for IVIG resistance. Participants will be followed up to measure the rate and percentage of IVIG resistance throughout the study period. Data collection includes clinical evaluations and monitoring of patient outcomes related to cardiac health. The study aims to validate the scoring systems for better prediction of treatment resistance, which may help guide future treatment decisions. Participants will be involved in regular assessments over the year-long study period to track their response and health status.

CONDITIONS

Brief Title

European and North Indian Cohort of KaWasaki dIsease

Who Can Participate

Age: 1Year - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged less than 18 years at diagnosis
  • Diagnosis of Kawasaki disease according to the American Heart Association criteria
Not Eligible

You will not qualify if you...

  • Patients who do not meet the criteria for Kawasaki disease
  • Patients for which an alternative infectious diagnosis was not investigated and/or excluded

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Long-term Monitoring

Duration - Approximately 1 year

Participants diagnosed with Kawasaki disease are observed to assess IVIG resistance over an average of 1 year.

Trial Site Locations

Total: 27 locations

1

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Brazil

Actively Recruiting

2

Children's Hospital Zagreb

Zagreb, Croatia

Actively Recruiting

3

University Hospital Centre Zagreb, University School of Medicine

Zagreb, Croatia

Actively Recruiting

4

Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI

Le Kremlin-Bicêtre, France

Not Yet Recruiting

5

Manipal Hospital

Bangalore, India

Not Yet Recruiting

6

Postgraduate Institute of Medical Education and Research

Chandigarh, India

Actively Recruiting

7

Sri Ramachandra Medical Centre

Chennai, India

Not Yet Recruiting

8

Amrita Institute of Medical Sciences

Kochi, India

Not Yet Recruiting

9

Institute of Child Health

Kolkata, India

Actively Recruiting

10

Vivekananda Institute of Medical Sciences

Kolkata, India

Not Yet Recruiting

11

Meir Medical Centre

Kfar Saba, Israel

Not Yet Recruiting

12

ASST Papa Giovanni XXIII

Bergamo, Italy

Actively Recruiting

13

Spedali Civili

Brescia, Italy

Actively Recruiting

14

Meyer Children's Hospital IRCCS

Florence, Italy

Actively Recruiting

15

IRCCS Istituto Giannina Gaslini

Genova, Italy

Actively Recruiting

16

Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico

Milan, Italy

Not Yet Recruiting

17

P.O. "Giovanni Di Cristina"

Palermo, Italy

Not Yet Recruiting

18

Università di Torino

Torino, Italy

Actively Recruiting

19

IRCCS Burlo Garofolo

Trieste, Italy

Actively Recruiting

20

Beatrix Kinderkliniek, University Medical Center

Groningen, Netherlands

Not Yet Recruiting

21

Hospital de Sabadell

Barcelona, Spain

Actively Recruiting

22

Hospital Sant Joan de Déu

Barcelona, Spain

Actively Recruiting

23

Chiang Mai University Hospital

Chiang Mai, Thailand

Actively Recruiting

24

Hacettepe University Children's Hospital

Ankara, Turkey (Türkiye)

Actively Recruiting

25

Health Sciences University, Umraniye Education and Research Hospital

Istanbul, Turkey (Türkiye)

Actively Recruiting

26

Istanbul Uni. Istanbul Med.Fac

Istanbul, Turkey (Türkiye)

Not Yet Recruiting

27

Royal Hospital for Children

Bristol, United Kingdom

Actively Recruiting

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Research Team

G

Gabriele Simonini

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Predictive value for intravenous immunoglobulin resistance of Kobayashi and Kawanet scores in 722 children with Kawasaki disease across diverse ethnic backgrounds (KIWI study): an international cohort study.

Maria Vincenza Mastrolia, Vignesh Pandiarajan, Marco Cattalini...

https://pubmed.ncbi.nlm.nih.gov/41809203