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KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)
NCT03065244 · View on ClinicalTrials.gov ↗
Study Summary
Kawasaki disease (KD) is a self-limited illness that affects the heart blood vessels (coronary arteries) of infants and children and is now the most common cause of acquired heart disease in children. A mixture of proteins from human blood (Intravenous immunoglobulin, IVIG) is a treatment that reduces the rate of the major complication of the disease: a bulging of the wall of the coronary arteries called an aneurysm. However, 10-20% of children are resistant to this treatment and the fever returns. These children have the highest rates of aneurysm formation and thus should be treated aggressively. Unfortunately, there are no guidelines for the best secondary treatment for these resistant patients because the problem has never been adequately studied. Most physicians choose either a second infusion of IVIG or an engineered antibody called infliximab that inactivates a molecule that promotes inflammation. This trial will randomize (assign by chance like the flip of a coin) IVIG-resistant patients to receive either a second IVIG infusion or infliximab and the response to treatment will be compared to learn which treatment stops the fever the fastest. In addition, parents and caregivers will provide observations about their child's response to the different treatments.
Conditions Studied
Interventions
- DRUG Infliximab
- DRUG IVIG
Study Locations (20)
California
- University of California San Diego — La Jolla
- Memorial Care — Long Beach
- Children's Hospital Los Angeles — Los Angeles
- David Geffen School of Medicine at UCLA — Los Angeles
- Harbor-UCLA Medical Center — Los Angeles
- UCSF Benioff Children's Hospital-Oakland — Oakland
- Children's Hospital of Orange County — Orange
- UCSF Benioff Children's Hospital-San Francisco — San Francisco
- Cedar-Sinai Medical Center — West Hollywood
Alabama
- UAB Children's of Alabama — Birmingham
Arkansas
- Arkansas Children's Hospital — Little Rock
Colorado
- Children's Hospital of Colorado — Aurora
District of Columbia
- Children's National Health SYstem — Washington D.C.
Georgia
- Children's Healthcare of Atlanta — Atlanta
Illinois
- Comer Children's Hospital — Chicago
Indiana
- Riley Children's Health Indiana University School of Medicine — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2017-02-17 |
| Est. Completion | 2020-11-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03065244
The ClinicalTrials.gov registry entry for NCT03065244 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 823 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Mucocutaneous Lymph Node Syndrome appearing as the primary indexed condition, and to 2 interventions — of which Infliximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03065244 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Alabama, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03065244 about?
NCT03065244 is a clinical study titled "KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)". Kawasaki disease (KD) is a self-limited illness that affects the heart blood vessels (coronary arteries) of infants and children and is now the most common cause of acquired heart disease in children. A mixture of proteins from human blood (Intravenous immunoglobulin, IVIG) is a treatment that reduc...
What is the current status of trial NCT03065244?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 2017-02-17. Estimated completion is 2020-11-02.
What conditions does trial NCT03065244 study?
This clinical trial studies the following conditions: Mucocutaneous Lymph Node Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03065244?
The interventions under investigation include: Infliximab (DRUG), IVIG (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03065244?
This trial is sponsored by University of California, San Diego, which has 823 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03065244 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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