European and North Indian Cohort of KaWasaki dIsease

Kawasaki Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06305611
• Other study ID #: KIWI
• Status: Recruiting
• Start date: July 13, 2021
• Est. completion date: October 30, 2024

Study information

• Verified date: March 2024
• Source: Meyer Children's Hospital IRCCS
• Contact: Gabriele Simonini
• Phone: 3297973141
• Email: gabriele.simonini[@]meyer.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 103
• Est. completion date: October 30, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio de Janeiro	Rio de Janeiro
Croatia	Children's Hospital Zagreb	Zagreb
Croatia	University Hospital Centre Zagreb, University School of Medicine	Zagreb
France	Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI	Le Kremlin-Bicêtre
India	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
Israel	Meir Medical Centre	Kfar Saba
Italy	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	Milano
Italy	P.O. "Giovanni Di Cristina"	Palermo
Italy	Università di Torino	Torino
Italy	IRCCS Burlo Garofolo	Trieste
Netherlands	Beatrix Kinderkliniek, University Medical Center	Groningen
Spain	Hospital de Sabadell	Barcellona
Spain	Hospital Sant Joan de Déu	Barcellona
Thailand	Chiang Mai University Hospital	Chiang Mai
Turkey	Hacettepe University Children's Hospital	Ankara
Turkey	Health Sciences University, Umraniye Education and Research Hospital	Istanbul
Turkey	Istanbul Uni. Istanbul Med.Fac	Istanbul
United Kingdom	Royal Hospital for Children	Bristol

Sponsors (1)

Lead Sponsor	Collaborator
Meyer Children's Hospital IRCCS

Countries where clinical trial is conducted

Brazil,  Croatia,  France,  India,  Israel,  Italy,  Netherlands,  Spain,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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