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New study aims to uncover hidden danger in kawasaki disease

NCT ID NCT07491926

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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will observe 150 children with Kawasaki disease to learn more about a rare but serious complication called Macrophage Activation Syndrome (MAS). Researchers will collect data on symptoms, lab results, and treatments across multiple European hospitals. The goal is to better understand how often MAS occurs, what puts children at risk, and how to diagnose it more accurately.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better ways to identify and treat MAS in children with Kawasaki disease, potentially preventing serious complications.
What could go wrong
This is an observational study, not a treatment trial. It may not directly change care, and results depend on accurate diagnosis and data collection across many hospitals.

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 150 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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

Since no validated or universally accepted diagnostic criteria currently exist for MAS occurring in the context of KD, the diagnosis of MAS will be based on the clinical judgment of the treating physician. To minimize the risk of misdiagnosis, all cases will be independently and critically reviewed by three experienced pediatric rheumatologists. Control groups will consist of age- and sex-matched patients, divided as follows: * Patients with KD resistant to first-line therapy * Patients with KD responsive to first-line therapy For each patient with KD complicated by MAS included in the study, 2 KD-responsive and 2 KD-resistant patients will be enrolled. The goal is to include at least 30 MAS-KD patients, along with 60 KD-resistant controls and 60 KD-responsive controls.

Ages

4 weeks 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: * Age between 4 weeks and under 18 years at the time of KD diagnosis * Diagnosis of KD made according to the 2024 AHA guidelines * Diagnosis of MAS made by the attending physician within 30 days from the onset of KD. Exclusion Criteria: * Unconfirmed diagnosis of KD (e.g., mimicking conditions) * Primary (genetic) HLH * Lack of informed consent * MAS diagnosed more than 30 days after or more than 15 days before the onset of KD

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Conditions

The condition(s) this trial relates to.

Kawasaki disease macrophage activation syndrome

As listed by the trial registrant

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

Kawasaki disease Macrophage activation syndrome (MAS)

How to take part

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

  1. The places running it

    1 site. 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

  • Azienda Ospedaliero-Universitaria IRCCS Meyer

    Florence, Italy, 50139, Italy

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