Clinical trial NCT06305611: European and North Indian Cohort of KaWasaki dIsease
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kawasaki Disease
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 103
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


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.

Primary outcomes:
measure: IVIG resistance rate
timeFrame: through study completion, an average of 1 year
measure: percentage of IVIG-resistant patients
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro
city: Zagreb
country: Croatia
facility: Children's Hospital Zagreb
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb, University School of Medicine
city: Le Kremlin-Bicêtre
country: France
facility: Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI
city: Bangalore
country: India
facility: Manipal Hospital
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
city: Chennai
country: India
facility: Sri Ramachandra Medical Centre
city: Kochi
country: India
facility: Amrita Institute of Medical Sciences
city: Kolkata
country: India
facility: Institute of Child Health
city: Kolkata
country: India
facility: Vivekananda Institute of Medical Sciences
city: Kfar Saba
country: Israel
facility: Meir Medical Centre
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Brescia
country: Italy
facility: Spedali Civili
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
city: Genova
country: Italy
facility: IRCCS Istituto Giannina Gaslini
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico
city: Palermo
country: Italy
facility: P.O. "Giovanni Di Cristina"
city: Torino
country: Italy
facility: Università di Torino
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
city: Groningen
country: Netherlands
facility: Beatrix Kinderkliniek, University Medical Center
city: Barcellona
country: Spain
facility: Hospital de Sabadell
city: Barcellona
country: Spain
facility: Hospital Sant Joan de Déu
city: Chiang Mai
country: Thailand
facility: Chiang Mai University Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Children's Hospital
city: Istanbul
country: Turkey
facility: Health Sciences University, Umraniye Education and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul Uni. Istanbul Med.Fac
city: Bristol
country: United Kingdom
facility: Royal Hospital for Children
Study officials:
References: