Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT07291245

Conditions

Kawasaki Disease

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Kawasaki MATCH

Study Details

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

Study ID

NCT07291245

Start date

Mar 1, 2025

Status verified date

Dec, 2025

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Kawasaki MATCH

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

no intervention: Routine Care

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

Interventions

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.

Primary outcome measure

  • Time to Kawasaki Disease treatment (KD patients only) [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Michael A Gardiner, MD

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

Locations

Rady Children's Hospital, San Diego

Recruiting

San Diego, California, United States, 92071

Contacts

Michael A Gardiner, MD

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

More Information

Sponsor

University of California, San Diego

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-12-18.