NYMC Faculty Publications


The Kawasaki Disease Comparative Effectiveness (KIDCARE) trial: A Phase III, Randomized Trial of Second Intravenous Immunoglobulin Versus Infliximab for Resistant Kawasaki Disease

First Page


Last Page


Document Type


Publication Date

April 2019




BACKGROUND: Although intravenous immunoglobulin (IVIG) is effective therapy for Kawasaki disease (KD), the most common cause of acquired heart disease in children, 10-20% of patients are IVIG-resistant and require additional therapy. This group has an increased risk of coronary artery aneurysms (CAA) and there has been no adequately powered, randomized clinical trial in a multi-ethnic population to determine the optimal therapy for IVIG-resistant patients. OBJECTIVES: The primary outcome is duration of fever in IVIG-resistant patients randomized to treatment with either infliximab or a second IVIG infusion. Secondary outcomes include comparison of inflammatory markers, duration of hospitalization, and coronary artery outcome. An exploratory aim records parent-reported outcomes including signs, symptoms and treatment experience. METHODS: The KIDCARE trial is a 30-site randomized Phase III comparative effectiveness trial in KD patients with fever >/=36h after the completion of their first IVIG treatment. Eligible patients will be randomized to receive either a second dose of IVIG (2g/kg) or infliximab (10mg/kg). Subjects with persistent or recrudescent fever at 24h following completion of the first study treatment will cross-over to the other treatment arm. Subjects will exit the study after their first outpatient visit (5-18days following last study treatment). The parent-reported outcomes, collected daily during hospitalization and at home, will be compared by study arm. CONCLUSION: This trial will contribute to the management of IVIG-resistant patients by establishing the relative efficacy of a second dose of IVIG compared to infliximab and will provide data regarding the patient/parent experience of these treatments.


Please see the work itself for the complete list of authors.