Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2025-03-01
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Kawasaki MATCH
Providers encouraged to access and utilize the Kawasaki MATCH decision support tool when evaluating and managing patients in the Emergency Department
Kawasaki MATCH
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.
Routine Care
Providers prompted to manage patients as per usual/routine care without additional decision support.
No interventions assigned to this group
Interventions
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Kawasaki MATCH
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Genetic disorders
* Current systemic steroid, immunosuppression, or chemotherapy treatment (not including inhaled steroids)
30 Days
17 Years
ALL
No
Sponsors
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Gordon and Marilyn Macklin Foundation
UNKNOWN
Rady Children's Hospital, San Diego
OTHER
University of California, San Diego
OTHER
Responsible Party
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Michael Gardiner
Associate Clinical Professor, Associate Division Chief of Research
Locations
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Rady Children's Hospital, San Diego
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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Michael A Gardiner, MD
Role: primary
References
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Lam JY, Shimizu C, Gardiner MA, Giorgio T, Wright V, Baker A, Anderson MS, Heizer H, Mohandas S, Kazarians A, Kaneta K, Jone PN, Dominguez SR, Szmuszkovicz JR, Newburger JW, Tremoulet AH, Burns JC. External Validation of a Machine Learning Model to Diagnose Kawasaki Disease. J Pediatr. 2025 Jul;282:114543. doi: 10.1016/j.jpeds.2025.114543. Epub 2025 Mar 21.
Lam JY, Shimizu C, Tremoulet AH, Bainto E, Roberts SC, Sivilay N, Gardiner MA, Kanegaye JT, Hogan AH, Salazar JC, Mohandas S, Szmuszkovicz JR, Mahanta S, Dionne A, Newburger JW, Ansusinha E, DeBiasi RL, Hao S, Ling XB, Cohen HJ, Nemati S, Burns JC; Pediatric Emergency Medicine Kawasaki Disease Research Group; CHARMS Study Group. A machine-learning algorithm for diagnosis of multisystem inflammatory syndrome in children and Kawasaki disease in the USA: a retrospective model development and validation study. Lancet Digit Health. 2022 Oct;4(10):e717-e726. doi: 10.1016/S2589-7500(22)00149-2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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68060
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
140220
Identifier Type: -
Identifier Source: org_study_id