Observing Kawasaki disease in European and North Indian children
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)
This study looks at children with Kawasaki disease to see if certain scoring systems can help identify those who don't respond to standard treatment, focusing on kids from Europe and North India.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 103 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 27 sites (Rio de Janeiro and 26 other locations) |
| Trial ID | NCT06305611 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on Kawasaki disease (KD), which is a leading cause of acquired heart disease in children. It aims to identify patients who are resistant to standard treatment with intravenous immunoglobulin (IVIG) by utilizing scoring systems developed in previous studies. The study will assess the effectiveness of these scoring systems in predicting treatment resistance across different ethnic populations, particularly in European and North Indian cohorts. By understanding the variations in treatment response, the study seeks to improve initial therapy strategies for KD patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old who have been diagnosed with Kawasaki disease according to the American Heart Association criteria.
Not a fit: Patients who do not meet the criteria for Kawasaki disease or have alternative infectious diagnoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification of Kawasaki disease patients who require more aggressive treatment, potentially reducing the risk of serious cardiac complications.
How similar studies have performed: Previous studies have shown varying success with similar scoring systems in predicting treatment resistance, but their effectiveness in diverse ethnic populations remains to be confirmed.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rio de Janeiro and 26 other locations
- Universidade Federal do Rio de Janeiro — Rio de Janeiro, Brazil (Recruiting)
- Children's Hospital Zagreb — Zagreb, Croatia (Recruiting)
- University Hospital Centre Zagreb, University School of Medicine — Zagreb, Croatia (Recruiting)
- Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI — Le Kremlin-Bicêtre, France (Not_yet_recruiting)
- Manipal Hospital — Bangalore, India (Not_yet_recruiting)
- Postgraduate Institute of Medical Education and Research — Chandigarh, India (Recruiting)
- Sri Ramachandra Medical Centre — Chennai, India (Not_yet_recruiting)
- Amrita Institute of Medical Sciences — Kochi, India (Not_yet_recruiting)
- Institute of Child Health — Kolkata, India (Recruiting)
- Vivekananda Institute of Medical Sciences — Kolkata, India (Not_yet_recruiting)
- Meir Medical Centre — Kfar Saba, Israel (Not_yet_recruiting)
- ASST Papa Giovanni XXIII — Bergamo, Italy (Recruiting)
- Spedali Civili — Brescia, Italy (Recruiting)
- Meyer Children's Hospital IRCCS — Florence, Italy (Recruiting)
- IRCCS Istituto Giannina Gaslini — Genova, Italy (Recruiting)
- Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico — Milan, Italy (Not_yet_recruiting)
- P.O. "Giovanni Di Cristina" — Palermo, Italy (Not_yet_recruiting)
- Università di Torino — Torino, Italy (Recruiting)
- IRCCS Burlo Garofolo — Trieste, Italy (Recruiting)
- Beatrix Kinderkliniek, University Medical Center — Groningen, Netherlands (Not_yet_recruiting)
- Hospital de Sabadell — Barcelona, Spain (Recruiting)
- Hospital Sant Joan de Déu — Barcelona, Spain (Recruiting)
- Chiang Mai University Hospital — Chiang Mai, Thailand (Recruiting)
- Hacettepe University Children's Hospital — Ankara, Turkey (Türkiye) (Recruiting)
- Health Sciences University, Umraniye Education and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
- Istanbul Uni. Istanbul Med.Fac — Istanbul, Turkey (Türkiye) (Not_yet_recruiting)
- Royal Hospital for Children — Bristol, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Gabriele Simonini
- Email: gabriele.simonini@meyer.it
- Phone: 3297973141
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.