Actively Recruiting
Evaluating Kobayashi and Kawanet Scores for IVIG Resistance in Children with Kawasaki Disease in Europe and North India
Led by Meyer Children's Hospital IRCCS · Updated on 2025-09-29
103
Participants Needed
27
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Kawasaki disease KD is a leading cause of acquired heart disease in children, particularly in developed countries. The study evaluates the performance of two scoring systems, Kobayashi and Kawanet, which aim to predict resistance to intravenous immunoglobulin IVIG treatment in KD patients. Resistance to IVIG occurs in 10-20% of patients and poses a significant risk for cardiac complications like coronary aneurysms. The study focuses on a multi-center European and North Indian cohort to assess the sensitivity and specificity of these scores in non-Asian populations. This observational study does not involve experimental treatments but monitors KD patients aged 1 to 17 years diagnosed according to American Heart Association AHA criteria. It compares the Kobayashi and Kawanet IVIG resistance scores to determine their accuracy in predicting which patients may not respond to standard IVIG therapy. The study spans an average duration of one year during which patients are observed for IVIG resistance. Participants will be followed up to measure the rate and percentage of IVIG resistance throughout the study period. Data collection includes clinical evaluations and monitoring of patient outcomes related to cardiac health. The study aims to validate the scoring systems for better prediction of treatment resistance, which may help guide future treatment decisions. Participants will be involved in regular assessments over the year-long study period to track their response and health status.
CONDITIONS
Brief Title
European and North Indian Cohort of KaWasaki dIsease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged less than 18 years at diagnosis
- Diagnosis of Kawasaki disease according to the American Heart Association criteria
You will not qualify if you...
- Patients who do not meet the criteria for Kawasaki disease
- Patients for which an alternative infectious diagnosis was not investigated and/or excluded
Research Team
G
Gabriele Simonini
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