European and North Indian Cohort of KaWasaki dIsease

Официальное название

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)

Обзор

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.

Первичные конечные точки

• IVIG resistance rate [Срок оценки: through study completion, an average of 1 year]
• percentage of IVIG-resistant patients [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Patients aged less than 18 years at diagnosis
• Diagnosis of KD according to the AHA criteria

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 8 центров

• ASST Papa Giovanni XXIII — Bergamo
• Spedali Civili — Brescia
• Meyer Children's Hospital IRCCS — Florence
• IRCCS Istituto Giannina Gaslini — Genova
• Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico — Milan
• P.O. "Giovanni Di Cristina" — Palermo
• Università di Torino — Torino
• IRCCS Burlo Garofolo — Trieste

Индия · 6 центров

• Manipal Hospital — Bangalore
• Postgraduate Institute of Medical Education and Research — Chandigarh
• Sri Ramachandra Medical Centre — Chennai
• Amrita Institute of Medical Sciences — Kochi
• Institute of Child Health — Kolkata
• Vivekananda Institute of Medical Sciences — Kolkata

Turkey (Türkiye) · 3 центра

• Hacettepe University Children's Hospital — Ankara
• Health Sciences University, Umraniye Education and Research Hospital — Istanbul
• Istanbul Uni. Istanbul Med.Fac — Istanbul

Хорватия · 2 центра

• Children's Hospital Zagreb — Zagreb
• University Hospital Centre Zagreb, University School of Medicine — Zagreb

Испания · 2 центра

• Hospital de Sabadell — Barcelona
• Hospital Sant Joan de Déu — Barcelona

Бразилия · 1 центр

• Universidade Federal do Rio de Janeiro — Rio de Janeiro

Франция · 1 центр

• Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI — Le Kremlin-Bicêtre

Израиль · 1 центр

• Meir Medical Centre — Kfar Saba

Нидерланды · 1 центр

• Beatrix Kinderkliniek, University Medical Center — Groningen

Таиланд · 1 центр

• Chiang Mai University Hospital — Chiang Mai

Великобритания · 1 центр

• Royal Hospital for Children — Bristol

Публикации

• Mastrolia MV, Pandiarajan V, Cattalini M, Taddio A, Vergnano S, Anton J, Sontichai W, Sozeri B, Ozen S, Rosina S, Sanchez-Manubens J, Haviv R, Pal P, Fonseca AR, Gagro A, Bagri NK, Verdoni L, Montin D, Maggio MC, Thangaraj A, Pilania R, Mosquera M, Calzada J, Sittiwangkul R, Ulu K, Balik Z, Bilginer Y, Garrone M, Patrone E, Barbi E, Ciacci G, Barucci A, Ruperto N, Simonini G. Predictive value for PMID 41809203

Идентификаторы

NCT: NCT06305611 · KIWI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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