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Can a simple score predict which kids with kawasaki disease need stronger treatment?

NCT ID NCT06305611

Knowledge-focused Sponsor: Meyer Children's Hospital IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at two scoring tools (Kobayashi and Kawanet) to see if they can identify children with Kawasaki disease who are likely to resist standard IVIG treatment. About 10-20% of children don't respond to IVIG and face a higher risk of heart problems. Researchers will enroll 103 children from Europe and North India to check how well these scores work across different ethnic groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 103 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

1 year to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Kawasaki disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kawasaki disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Papa Giovanni XXIII

    RECRUITING

    Bergamo, Italy

  • Amrita Institute of Medical Sciences

    NOT_YET_RECRUITING

    Kochi, India

  • Beatrix Kinderkliniek, University Medical Center

    NOT_YET_RECRUITING

    Groningen, Netherlands

  • Chiang Mai University Hospital

    RECRUITING

    Chiang Mai, Thailand

  • Children's Hospital Zagreb

    RECRUITING

    Zagreb, Croatia

  • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico

    NOT_YET_RECRUITING

    Milan, Italy

  • Hacettepe University Children's Hospital

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Health Sciences University, Umraniye Education and Research Hospital

    RECRUITING

    Istanbul, Turkey (Türkiye)

  • Hospital Sant Joan de Déu

    RECRUITING

    Barcelona, Spain

  • Hospital de Sabadell

    RECRUITING

    Barcelona, Spain

  • IRCCS Burlo Garofolo

    RECRUITING

    Trieste, Italy

  • IRCCS Istituto Giannina Gaslini

    RECRUITING

    Genova, Italy

  • Institute of Child Health

    RECRUITING

    Kolkata, India

  • Istanbul Uni. Istanbul Med.Fac

    NOT_YET_RECRUITING

    Istanbul, Turkey (Türkiye)

  • Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI

    NOT_YET_RECRUITING

    Le Kremlin-Bicêtre, France

  • Manipal Hospital

    NOT_YET_RECRUITING

    Bangalore, India

  • Meir Medical Centre

    NOT_YET_RECRUITING

    Kfar Saba, Israel

  • Meyer Children's Hospital IRCCS

    RECRUITING

    Florence, Italy

  • P.O. "Giovanni Di Cristina"

    NOT_YET_RECRUITING

    Palermo, Italy

  • Postgraduate Institute of Medical Education and Research

    RECRUITING

    Chandigarh, India

  • Royal Hospital for Children

    RECRUITING

    Bristol, United Kingdom

  • Spedali Civili

    RECRUITING

    Brescia, Italy

  • Sri Ramachandra Medical Centre

    NOT_YET_RECRUITING

    Chennai, India

  • Universidade Federal do Rio de Janeiro

    RECRUITING

    Rio de Janeiro, Brazil

  • University Hospital Centre Zagreb, University School of Medicine

    RECRUITING

    Zagreb, Croatia

  • Università di Torino

    RECRUITING

    Torino, Italy

  • Vivekananda Institute of Medical Sciences

    NOT_YET_RECRUITING

    Kolkata, India

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