European and North Indian Cohort of KaWasaki dIsease

March 5, 2024 updated by: Gabriele Simonini, Meyer Children's Hospital IRCCS

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)

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil
        • Recruiting
        • Universidade Federal do Rio de Janeiro
        • Contact:
          • Adriana Fonseca
  • Croatia
      • Zagreb, Croatia
        • Recruiting
        • Children's Hospital Zagreb
        • Contact:
          • Alenka Gagro
      • Zagreb, Croatia
        • Recruiting
        • University Hospital Centre Zagreb, University School of Medicine
        • Contact:
          • Marija Jelusic
  • France
      • Le Kremlin-Bicêtre, France
        • Not yet recruiting
        • Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI
        • Contact:
          • Isabelle Koné-Paut
  • India
      • Bangalore, India
        • Not yet recruiting
        • Manipal Hospital
        • Contact:
          • Anand Prahalad Rao
      • Chandigarh, India
        • Recruiting
        • Postgraduate Institute of Medical Education and Research
        • Contact:
          • Vignesh Pandiarajan
      • Chennai, India
        • Not yet recruiting
        • Sri Ramachandra Medical Centre
        • Contact:
          • Mahesh Janarthanan
      • Kochi, India
        • Not yet recruiting
        • Amrita Institute of Medical Sciences
        • Contact:
          • Suma Balan
      • Kolkata, India
        • Recruiting
        • Institute of Child Health
        • Contact:
          • Priyankar Pal
      • Kolkata, India
        • Not yet recruiting
        • Vivekananda Institute of Medical Sciences
        • Contact:
          • SUPARNA GUHA
  • Israel
      • Kfar Saba, Israel
        • Not yet recruiting
        • Meir Medical Centre
        • Contact:
          • Ruby Haviv
  • Italy
      • Bergamo, Italy
        • Recruiting
        • ASST Papa Giovanni XXIII
        • Contact:
          • Lucio Verdoni
      • Brescia, Italy
        • Recruiting
        • Spedali Civili
        • Contact:
          • Marco Cattalini
      • Florence, Italy
      • Genova, Italy
        • Recruiting
        • IRCCS Istituto Giannina Gaslini
        • Contact:
          • Silvia Rosina
      • Milano, Italy
        • Not yet recruiting
        • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico
        • Contact:
          • Giovanni Filocamo
      • Palermo, Italy
        • Not yet recruiting
        • P.O. "Giovanni Di Cristina"
        • Contact:
          • Maria Cristina Maggio
      • Torino, Italy
        • Recruiting
        • Università di Torino
        • Contact:
          • Francesco Licciardi
      • Trieste, Italy
        • Recruiting
        • IRCCS Burlo Garofolo
        • Contact:
          • andrea Taddio
  • Netherlands
      • Groningen, Netherlands
        • Not yet recruiting
        • Beatrix Kinderkliniek, University Medical Center
        • Contact:
          • Wineke Armbrust
  • Spain
      • Barcellona, Spain
        • Recruiting
        • Hospital de Sabadell
        • Contact:
          • Judith Sanchez Manubens
      • Barcellona, Spain
        • Recruiting
        • Hospital Sant Joan de Déu
        • Contact:
          • Jordi Anton
  • Thailand
      • Chiang Mai, Thailand
        • Recruiting
        • Chiang Mai University Hospital
        • Contact:
          • Watchareewan Sontichai
  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Hacettepe University Children's Hospital
        • Contact:
          • Seza Ozen
      • Istanbul, Turkey
        • Recruiting
        • Health Sciences University, Umraniye Education and Research Hospital
        • Contact:
          • Betul Sozeri
      • Istanbul, Turkey
        • Not yet recruiting
        • Istanbul Uni. Istanbul Med.Fac
        • Contact:
          • Nuray Aktay Ayaz
  • United Kingdom
      • Bristol, United Kingdom
        • Recruiting
        • Royal Hospital for Children
        • Contact:
          • Athimalaipet Ramanan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IVIG resistance rate
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meyer Children's Hospital IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2021

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIWI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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