Kawasaki DiseaseNCT06305611
European and North Indian Cohort of KaWasaki dIsease
An observational study of Kawasaki Disease, run by Meyer Children's Hospital IRCCS at 27 sites in 11 countries.
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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Kawasaki Disease
- How many people
- 103 participants
- Where
- 27 sitesin 11 countries
- Study dates
- 13 Jul 2021to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study 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
Who may be able to join
- Patients aged less than 18 years at diagnosis
- Diagnosis of KD according to the AHA criteria
Who cannot join
- Patients who do not meet the criteria for KD
- Patients for which an alternative infectious diagnosis was not investigated and/or excluded.
Trial locations and contacts
27 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 11 countries
Italy8 sites, 8 recruiting
- Recruiting
ASST Papa Giovanni XXIII
Bergamo
Lucio Verdoni
- Recruiting
Spedali Civili
Brescia
Marco Cattalini
- Recruiting
Meyer Children's Hospital IRCCS
Florence
Gabriele Simonini, gabriele.simonini@meyer.it
- Recruiting
IRCCS Istituto Giannina Gaslini
Genova
Silvia Rosina
- Not yet recruiting
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico
Milan
Giovanni Filocamo
- Not yet recruiting
P.O. "Giovanni Di Cristina"
Palermo
Maria Cristina Maggio
- Recruiting
Università di Torino
Torino
Francesco Licciardi
- Recruiting
IRCCS Burlo Garofolo
Trieste
andrea Taddio
India6 sites, 6 recruiting
- Not yet recruiting
Manipal Hospital
Bangalore
Anand Prahalad Rao
- Recruiting
Postgraduate Institute of Medical Education and Research
Chandigarh
Vignesh Pandiarajan
- Not yet recruiting
Sri Ramachandra Medical Centre
Chennai
Mahesh Janarthanan
- Not yet recruiting
Amrita Institute of Medical Sciences
Kochi
Suma Balan
- Recruiting
Institute of Child Health
Kolkata
Priyankar Pal
- Not yet recruiting
Vivekananda Institute of Medical Sciences
Kolkata
SUPARNA GUHA
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Hacettepe University Children's Hospital
Ankara
Seza Ozen
- Recruiting
Health Sciences University, Umraniye Education and Research Hospital
Istanbul
Betul Sozeri
- Not yet recruiting
Istanbul Uni. Istanbul Med.Fac
Istanbul
Nuray Aktay Ayaz
Croatia2 sites, 2 recruiting
- Recruiting
Children's Hospital Zagreb
Zagreb
Alenka Gagro
- Recruiting
University Hospital Centre Zagreb, University School of Medicine
Zagreb
Marija Jelusic
Spain2 sites, 2 recruiting
- Recruiting
Hospital de Sabadell
Barcelona
Judith Sanchez Manubens
- Recruiting
Hospital Sant Joan de Déu
Barcelona
Jordi Anton
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal do Rio de Janeiro
Rio de Janeiro
Adriana Fonseca
France1 site, 1 recruiting
- Not yet recruiting
Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI
Le Kremlin-Bicêtre
Isabelle Koné-Paut
Israel1 site, 1 recruiting
- Not yet recruiting
Meir Medical Centre
Kfar Saba
Ruby Haviv
Netherlands1 site, 1 recruiting
- Not yet recruiting
Beatrix Kinderkliniek, University Medical Center
Groningen
Wineke Armbrust
Thailand1 site, 1 recruiting
- Recruiting
Chiang Mai University Hospital
Chiang Mai
Watchareewan Sontichai
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Hospital for Children
Bristol
Athimalaipet Ramanan
About this study
Official title: 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)
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.
- Conditions
- Kawasaki Disease
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
IVIG resistance rate
IVIG resistance rate in patients with KD and stratification according to different ethnic groups.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start13 Jul 2021
- Primary completion15 Jul 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Simonini, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305611
- Sponsor's protocol ID
- KIWI
- Status last verified
- Sep 2025
- First submitted
- 16 Feb 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mastrolia MV, Pandiarajan V, Cattalini M, Taddio A, Vergnano S, Anton J, Sontichai W, Sozeri B, Ozen S, Rosina S, Sanchez-Manubens J, Haviv R, Pal P, Fonseca AR, Gagro A, Bagri NK, Verdoni L, Montin D, Maggio MC, Thangaraj A, Pilania R, Mosquera M, Calzada J, Sittiwangkul R, Ulu K, Balik Z, Bilginer Y, Garrone M, Patrone E, Barbi E, Ciacci G, Barucci A, Ruperto N, Simonini G. Predictive value for intravenous immunoglobulin resistance of Kobayashi and Kawanet scores in 722 children with Kawasaki disease across diverse ethnic backgrounds (KIWI study): an international cohort study. EClinicalMedicine. 2026 Mar 4;93:103813. doi: 10.1016/j.eclinm.2026.103813. eCollection 2026 Mar.
PubMed 41809203
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06305611
- Acronym / sponsor ID
- KIWI
- Conditions
- Kawasaki Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study 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
Key inclusion criteria (2 listed)
- Patients aged less than 18 years at diagnosis
- Diagnosis of KD according to the AHA criteria
Key exclusion criteria (2 listed)
- Patients who do not meet the criteria for KD
- Patients for which an alternative infectious diagnosis was not investigated and/or excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IVIG resistance rate
Time frame: through study completion, an average of 1 year
IVIG resistance rate in patients with KD and stratification according to different ethnic groups.
percentage of IVIG-resistant patients
Time frame: through study completion, an average of 1 year
percentage of IVIG-resistant patients who met the Kobayashi and KAWANET criteria, and specificity and sensitivity of the criteria within the different ethnic groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Derived from this study: PubMed 41809203Mastrolia MV, Pandiarajan V, Cattalini M, Taddio A, Vergnano S, Anton J, Sontichai W, Sozeri B, Ozen S, Rosina S, Sanchez-Manubens J, Haviv R, Pal P, Fonseca AR, Gagro A, Bagri NK, Verdoni L, Montin D, Maggio MC, Thangaraj A, Pilania R, Mosquera M, Calzada J, Sittiwangkul R, Ulu K, Balik Z, Bilginer Y, Garrone M, Patrone E, Barbi E, Ciacci G, Barucci A, Ruperto N, Simonini G. Predictive value for intravenous immunoglobulin resistance of Kobayashi and Kawanet scores in 722 children with Kawasaki disease across diverse ethnic backgrounds (KIWI study): an international cohort study. EClinicalMedicine. 2026 Mar 4;93:103813. doi: 10.1016/j.eclinm.2026.103813. eCollection 2026 Mar.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
27 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kawasaki Disease, run by Meyer Children's Hospital IRCCS at 27 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Italy, India, Turkey (Türkiye), Croatia, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Simonini (3297973141, gabriele.simonini@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IVIG resistance rate (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06305611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.