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NCT Number: NCT07291245

Kawasaki MATCH Trial

Evaluating the impact of a machine-learning clinical decision support tool on provider practice when evaluating febrile patients with Kawasaki Disease (KD) and non-KD illnesses.

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Key information

Conditions

Kawasaki Disease Cardiovascular Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Mucocutaneous Lymph Node Syndrome Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

30 day–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rady Children's Hospital, San Diego

San Diego, California, 92071, United States

Location status: Recruiting

Location contact

Michael A Gardiner, MD

CONTACT

[email protected]

949-310-4808

About this study

Following laboratory evaluation, providers will be randomized to treat patients according to usual practice/standard of care vs. receiving clinical decision support from the Kawasaki MATCH tool - a previously validated machine-learning clinical decision support tool to identify Kawasaki Disease. The study aim is to evaluate the accuracy of Kawasaki MATCH prospectively when used at the point of care, as well as how this tool impacts clinical decisions including additional evaluation and hospital admission.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Measured or subjective fever for >= 3 calendar days
  • One measured fever >= 38.0 C (home or in ED)
  • One or more clinical feature of Kawasaki Disease including:
  • Rash
  • Conjunctival injection
  • Oropharyngeal changes
  • Extremity changes (erythema, edema, desquamation)
  • Cervical adenopathy (>=1.5cm)
  • Infants < 6 months of age with >= 7 days of fever eligible even if none of the above clinical features
  • Requires IV/phlebotomy for clinical evaluation

Exclusion criteria

  • Congenital or Acquired Immune function
  • Genetic disorders
  • Current systemic steroid, immunosuppression, or chemotherapy treatment (not including inhaled steroids)

Treatment and study plan

Kawasaki MATCH

Other

Providers access the Kawasaki MATCH decision support tool. Patient information is entered into the tool and a risk score is indicated to the provider. Kawasaki MATCH is a previously validated machine-learning decision support tool for the diagnosis of Kawasaki Disease. This tool utilizes patient age, 18 laboratory features, and 5 clinical features to formulate a risk score.

Primary outcomes

  1. Time to Kawasaki Disease treatment (KD patients only)

    Time frame: 90 days

    Time in days from initial ED evaluation to initial IVIG treatment in patients ultimately diagnosed with Kawasaki Disease

Secondary outcomes

  1. Kawasaki MATCH score

    Time frame: Day 1 (day of enrollment)

    MATCH score determined by entering patient clinical and laboratory information into the Kawasaki MATCH algorithm. Algorithm output is a decimal between 0 and 1. Scores less than 0.4 will be deemed a prediction of "not Kawasaki Disease" while scores of 0.4 or higher will be deemed "Kawasaki Disease"

  2. Hospital Admission Rate

    Time frame: Day 1 (day of enrollment)

    Proportion of patients admitted to the hospital from the Emergency Department (ED).

    Admitted patients = 1 Discharged patients = 0

  3. Kawasaki Disease consultation rate

    Time frame: Day 1 (day of enrollment)

    Proportion of patients receiving Kawasaki service consultation

  4. ED return visit

    Time frame: 7 days

    Return to Emergency Department

  5. Additional interventions

    Time frame: Day 1 (day of enrollment)

    Additional ED orders for laboratory/imaging studies or additional procedures after the time of randomization

  6. Provider assessment of KD likelihood - baseline

    Time frame: Day 1 (day of enrollment)

    Visual analog scale of suspected likelihood of Kawasaki Disease. Scale between 0 (Definitely not Kawasaki Disease) and 100 (Definitely Kawasaki Disease) with higher values indicating higher provider suspicion for Kawasaki Disease.

    This outcome will be assessed on providers randomized to both study arms

  7. Provider assessment of KD likelihood - after algorithm

    Time frame: Day 1 (day of enrollment)

    Visual analog scale of suspected likelihood of Kawasaki Disease. Scale between 0 (Definitely not Kawasaki Disease) and 100 (Definitely Kawasaki Disease) with higher values indicating higher provider suspicion for Kawasaki Disease.

    This outcome only assessed for providers in the experimental arm.

  8. Algorithm helpfulness

    Time frame: Day 1 (day of enrollment)

    Visual analog scale of the perceived helpfulness of the Kawasaki MATCH algorithm. Scale between 0 (Not helpful) and 100 (Extremely helpful) with higher values indicating increased helpfulness.

    This outcome only assessed for providers in the experimental arm.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael A Gardiner, MD

CONTACT

[email protected]

949-310-4808

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Gordon and Marilyn Macklin Foundation
  • Rady Children's Hospital, San Diego

Registry information

Official study title

Kawasaki MATCH: A Clinical Decision Support Tool to Detect KD

Acronym: MATCH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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