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)

Status: Recruiting
Location: See all (27) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:

• Patients aged less than 18 years at diagnosis

• Diagnosis of KD according to the AHA criteria

Locations
Other Locations
Brazil
Universidade Federal do Rio de Janeiro
RECRUITING
Rio De Janeiro
Croatia
Children's Hospital Zagreb
RECRUITING
Zagreb
University Hospital Centre Zagreb, University School of Medicine
RECRUITING
Zagreb
France
Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI
NOT_YET_RECRUITING
Le Kremlin-bicêtre
India
Manipal Hospital
NOT_YET_RECRUITING
Bangalore
Postgraduate Institute of Medical Education and Research
RECRUITING
Chandigarh
Sri Ramachandra Medical Centre
NOT_YET_RECRUITING
Chennai
Amrita Institute of Medical Sciences
NOT_YET_RECRUITING
Kochi
Institute of Child Health
RECRUITING
Kolkata
Vivekananda Institute of Medical Sciences
NOT_YET_RECRUITING
Kolkata
Israel
Meir Medical Centre
NOT_YET_RECRUITING
Kfar Saba
Italy
ASST Papa Giovanni XXIII
RECRUITING
Bergamo
Spedali Civili
RECRUITING
Brescia
Meyer Children's Hospital IRCCS
RECRUITING
Florence
IRCCS Istituto Giannina Gaslini
RECRUITING
Genova
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico
NOT_YET_RECRUITING
Milan
P.O. Giovanni Di Cristina
NOT_YET_RECRUITING
Palermo
Università di Torino
RECRUITING
Torino
IRCCS Burlo Garofolo
RECRUITING
Trieste
Netherlands
Beatrix Kinderkliniek, University Medical Center
NOT_YET_RECRUITING
Groningen
Spain
Hospital de Sabadell
RECRUITING
Barcelona
Hospital Sant Joan de Déu
RECRUITING
Barcelona
Thailand
Chiang Mai University Hospital
RECRUITING
Chiang Mai
Turkey
Hacettepe University Children's Hospital
RECRUITING
Ankara
Health Sciences University, Umraniye Education and Research Hospital
RECRUITING
Istanbul
Istanbul Uni. Istanbul Med.Fac
NOT_YET_RECRUITING
Istanbul
United Kingdom
Royal Hospital for Children
RECRUITING
Bristol
Contact Information
Primary
Gabriele Simonini
gabriele.simonini@meyer.it
3297973141
Time Frame
Start Date: 2021-07-13
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 103
Related Therapeutic Areas
Sponsors
Leads: Meyer Children's Hospital IRCCS

This content was sourced from clinicaltrials.gov