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European and North Indian Cohort of KaWasaki dIsease

NCT ID: NCT06305611

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-13

Study Completion Date

2026-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Kawasaki Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meyer Children's Hospital IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Gabriele Simonini

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidade Federal do Rio de Janeiro

Rio de Janeiro, , Brazil

Site Status RECRUITING

Children's Hospital Zagreb

Zagreb, , Croatia

Site Status RECRUITING

University Hospital Centre Zagreb, University School of Medicine

Zagreb, , Croatia

Site Status RECRUITING

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

Le Kremlin-Bicêtre, , France

Site Status NOT_YET_RECRUITING

Manipal Hospital

Bangalore, , India

Site Status NOT_YET_RECRUITING

Postgraduate Institute of Medical Education and Research

Chandigarh, , India

Site Status RECRUITING

Sri Ramachandra Medical Centre

Chennai, , India

Site Status NOT_YET_RECRUITING

Amrita Institute of Medical Sciences

Kochi, , India

Site Status NOT_YET_RECRUITING

Institute of Child Health

Kolkata, , India

Site Status RECRUITING

Vivekananda Institute of Medical Sciences

Kolkata, , India

Site Status NOT_YET_RECRUITING

Meir Medical Centre

Kfar Saba, , Israel

Site Status NOT_YET_RECRUITING

ASST Papa Giovanni XXIII

Bergamo, , Italy

Site Status RECRUITING

Spedali Civili

Brescia, , Italy

Site Status RECRUITING

Meyer Children's Hospital IRCCS

Florence, , Italy

Site Status RECRUITING

IRCCS Istituto Giannina Gaslini

Genova, , Italy

Site Status RECRUITING

Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico

Milan, , Italy

Site Status NOT_YET_RECRUITING

P.O. "Giovanni Di Cristina"

Palermo, , Italy

Site Status NOT_YET_RECRUITING

Università di Torino

Torino, , Italy

Site Status RECRUITING

IRCCS Burlo Garofolo

Trieste, , Italy

Site Status RECRUITING

Beatrix Kinderkliniek, University Medical Center

Groningen, , Netherlands

Site Status NOT_YET_RECRUITING

Hospital de Sabadell

Barcelona, , Spain

Site Status RECRUITING

Hospital Sant Joan de Déu

Barcelona, , Spain

Site Status RECRUITING

Chiang Mai University Hospital

Chiang Mai, , Thailand

Site Status RECRUITING

Hacettepe University Children's Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Health Sciences University, Umraniye Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Istanbul Uni. Istanbul Med.Fac

Istanbul, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Royal Hospital for Children

Bristol, , United Kingdom

Site Status RECRUITING

Countries

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Brazil Croatia France India Israel Italy Netherlands Spain Thailand Turkey (Türkiye) United Kingdom

Central Contacts

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Gabriele Simonini

Role: CONTACT

[email protected]
3297973141

Facility Contacts

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Adriana Fonseca

Role: primary

Alenka Gagro

Role: primary

Marija Jelusic

Role: primary

Isabelle Koné-Paut

Role: primary

Anand Prahalad Rao

Role: primary

Vignesh Pandiarajan

Role: primary

Mahesh Janarthanan

Role: primary

Suma Balan

Role: primary

Priyankar Pal

Role: primary

SUPARNA GUHA

Role: primary

Ruby Haviv

Role: primary

Lucio Verdoni

Role: primary

Marco Cattalini

Role: primary

Gabriele Simonini

Role: primary

[email protected]

Silvia Rosina

Role: primary

Giovanni Filocamo

Role: primary

Maria Cristina Maggio

Role: primary

Francesco Licciardi

Role: primary

andrea Taddio

Role: primary

Wineke Armbrust

Role: primary

Judith Sanchez Manubens

Role: primary

Jordi Anton

Role: primary

Watchareewan Sontichai

Role: primary

Seza Ozen

Role: primary

Betul Sozeri

Role: primary

Nuray Aktay Ayaz

Role: primary

Athimalaipet Ramanan

Role: primary

Other Identifiers

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KIWI

Identifier Type: -

Identifier Source: org_study_id

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