Kawasaki MATCH Trial

NCT07291245 | Recruiting

• 2 other identifiers: 14022068060
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kawasaki Disease

Keywords

Kawasaki Disease; Machine-learning; Artificial Intelligence (AI); Decision support; Point-of-care

Outcome Measures

Primary Outcomes (1)

• Time to Kawasaki Disease treatment (KD patients only)

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

  90 days

Secondary Outcomes (8)

• Kawasaki MATCH score

  Day 1 (day of enrollment)

• Hospital Admission Rate

  Day 1 (day of enrollment)

• Kawasaki Disease consultation rate

  Day 1 (day of enrollment)

• ED return visit

  7 days

• Additional interventions

  Day 1 (day of enrollment)

Study Arms (2)

Kawasaki MATCH

EXPERIMENTAL

Providers encouraged to access and utilize the Kawasaki MATCH decision support tool when evaluating and managing patients in the Emergency Department

Other: Kawasaki MATCH

Routine Care

NO INTERVENTION

Providers prompted to manage patients as per usual/routine care without additional decision support.

Interventions

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.

Kawasaki MATCH

Eligibility Criteria

• Age: 30 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead
• Gordon and Marilyn Macklin Foundation: collaborator
• Rady Children's Hospital, San Diego: collaborator

Study Sites (1)

Rady Children's Hospital, San Diego

San Diego, California, 92071, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 40122277 BACKGROUND

• 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.

  PMID: 36150781 BACKGROUND

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Michael A Gardiner, MD

CONTACT

949-310-4808; magardiner@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor, Associate Division Chief of Research

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 18, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)