European and North Indian Cohort of KaWasaki dIsease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-17
SponsorMeyer Children's Hospital IRCCS

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients aged less than 18 years at diagnosis

Diagnosis of KD according to the AHA criteria

Disqualifiers

Patients who do not meet the criteria for KD

Patients for which an alternative infectious diagnosis was not investigated and/or excluded.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

IVIG resistance rate

IVIG resistance rate in patients with KD and stratification according to different ethnic groups.

Time frame
through study completion, an average of 1 year
2

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.

Time frame
through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.