At a glance
ClinicalIndex Comparison Record- ✓Age 4 weeks to 17 years
- ✓Meets American Heart Association case definition for complete or incomplete Kawasaki disease
- ✓Fever ≥38°C for 3–10 days before initial IVIG treatment
- ✓Persistent fever ≥38°C (orally or rectally) 36 hours to 7 days after end of first IVIG infusion with no other identified cause
- ✕Prior treatment with infliximab or systemic steroids for the current illness (oral steroids given as outpatients before KD diagnosis are permitted)
- ✕Known prior infection with tuberculosis, coccidiomycosis, or histoplasmosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)
In Brief
A Phase 3 clinical trial evaluating IVIG and Infliximab for Mucocutaneous Lymph Node Syndrome. Completed, enrolled 105 participants across 29 sites.
Detailed 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.
Study Details
Timeline
Interventions
Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours