Kawasaki DiseaseMATCHNCT07291245
Kawasaki MATCH Trial
A study testing Kawasaki MATCH in people with Kawasaki Disease, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 days to 17 years
- Conditions the study is for
- Kawasaki Disease
- What is being tested?
- Kawasaki MATCH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Congenital or Acquired Immune function
- Genetic disorders
- Current systemic steroid, immunosuppression, or chemotherapy treatment (not including inhaled steroids)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rady Children's Hospital, San Diego
San Diego, California, 92071
Michael A Gardiner, MD, 949-310-4808, magardiner@health.ucsd.edu
About this study
Official title: Kawasaki MATCH: A Clinical Decision Support Tool to Detect KD
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.
Read the detailed description
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.
- Conditions
- Kawasaki Disease
- Being tested
- Kawasaki MATCH
- Keywords
- Kawasaki Disease, Machine-learning, Artificial Intelligence (AI), Decision support, Point-of-care
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kawasaki MATCHOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Kawasaki MATCH | Experimental | Providers encouraged to access and utilize the Kawasaki MATCH decision support tool when evaluating and managing patients in the Emergency Department Receives: Other: Kawasaki MATCH |
| Routine Care | No intervention | Providers prompted to manage patients as per usual/routine care without additional decision support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (8)
Kawasaki MATCH score
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"
Measured: Day 1 (day of enrollment)
Hospital Admission Rate
Proportion of patients admitted to the hospital from the Emergency Department (ED).
Admitted patients = 1 Discharged patients = 0
Measured: Day 1 (day of enrollment)
Kawasaki Disease consultation rate
Proportion of patients receiving Kawasaki service consultation
Measured: Day 1 (day of enrollment)
ED return visit
Return to Emergency Department
Measured: 7 days
Additional interventions
Additional ED orders for laboratory/imaging studies or additional procedures after the time of randomization
Measured: Day 1 (day of enrollment)
Provider assessment of KD likelihood - baseline
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
Measured: Day 1 (day of enrollment)
Provider assessment of KD likelihood - after algorithm
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.
Measured: Day 1 (day of enrollment)
Algorithm helpfulness
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.
Measured: Day 1 (day of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Mar 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Gordon and Marilyn Macklin Foundation, Rady Children's Hospital, San Diego
- Responsible party
- Principal investigator, Michael Gardiner, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291245
- Sponsor's protocol ID
- 140220
- Other IDs
- 68060
- Acronym
- MATCH
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not included in consent documents
Publications
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.
PubMed 40122277Lam 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.
PubMed 36150781
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kawasaki MATCH: A Clinical Decision Support Tool to Detect KD
- ClinicalTrials.gov ID
- NCT07291245
- Acronym / sponsor ID
- MATCH / 140220
- Conditions
- Kawasaki Disease
- Keywords
- Kawasaki Disease, Machine-learning, Artificial Intelligence (AI), Decision support, Point-of-care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Gordon and Marilyn Macklin Foundation, Rady Children's Hospital, San Diego
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kawasaki MATCH | Experimental | Other: Kawasaki MATCHProviders encouraged to access and utilize the Kawasaki MATCH decision support tool when evaluating and managing patients in the Emergency Department |
| Routine Care | No intervention | –Providers prompted to manage patients as per usual/routine care without additional decision support. |
Who may qualify
- Ages
- 30 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- Congenital or Acquired Immune function
- Genetic disorders
- Current systemic steroid, immunosuppression, or chemotherapy treatment (not including inhaled steroids)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kawasaki MATCHProviders 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. | Other | Kawasaki MATCH |
Primary outcome
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
8 secondary outcomes
Kawasaki MATCH score
Time frame: Day 1 (day of enrollment)
Hospital Admission Rate
Time frame: Day 1 (day of enrollment)
Kawasaki Disease consultation rate
Time frame: Day 1 (day of enrollment)
ED return visit
Time frame: 7 days
Additional interventions
Time frame: Day 1 (day of enrollment)
Provider assessment of KD likelihood - baseline
Time frame: Day 1 (day of enrollment)
Provider assessment of KD likelihood - after algorithm
Time frame: Day 1 (day of enrollment)
Algorithm helpfulness
Time frame: Day 1 (day of enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 40122277Lam 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.
- Background: PubMed 36150781Lam 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.
- Individual participant dataSharing planned: No. Not included in consent documents
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kawasaki MATCH in people with Kawasaki Disease, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael A Gardiner, MD (949-310-4808, magardiner@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Kawasaki Disease treatment (KD patients only) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07291245, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.