Kawasaki MATCH decision support for suspected Kawasaki disease
Kawasaki MATCH: A Clinical Decision Support Tool to Detect KD
This study will test a machine-learning tool called Kawasaki MATCH to help providers decide if febrile children might have Kawasaki disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 30 Days to 17 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT07291245 on ClinicalTrials.gov |
What this trial studies
After laboratory evaluation, providers are randomized to follow usual care or to receive point-of-care recommendations from Kawasaki MATCH, a previously validated machine-learning clinical decision support tool. The trial measures the tool's diagnostic accuracy when used during routine care and records how it changes clinician actions such as additional testing or hospital admission. Eligible patients are children with multiple days of fever and one or more clinical features of Kawasaki disease (or infants under 6 months with prolonged fever) who require bloodwork. Study outcomes include prospective accuracy of the tool, changes in evaluation and admission decisions, and safety and feasibility of bedside use.
Who should consider this trial
Good fit: Children with measured or subjective fever for >= 3 days (or infants < 6 months with >= 7 days of fever), at least one fever >= 38.0°C, one or more Kawasaki clinical features, and who require IV/phlebotomy are the ideal candidates.
Not a fit: Patients without fever or those who do not require blood testing, patients with immunodeficiency or on systemic immunosuppression/chemotherapy, and children seen outside the participating hospital are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, Kawasaki MATCH could help clinicians identify Kawasaki disease earlier and make more consistent decisions about testing and hospital admission.
How similar studies have performed: Kawasaki MATCH has prior validation data showing promising diagnostic accuracy, but prospective, point-of-care testing of its impact on clinician decision-making is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
San Diego, California
- Rady Children's Hospital, San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Michael A Gardiner, MD
- Email: magardiner@health.ucsd.edu
- Phone: 949-310-4808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.