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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06305611
Other study ID # KIWI
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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