Kawasaki disease
Conditions
Interventions
Intravenous immunoglobulin (2 g/kg/day) over 24 hours with aspirin (30 mg/kg/day).The dosage of aspirin can be decreased to 5 mg/kg/day after becoming afebrile.
Intravenous immunoglobulin (2 g/kg/day)
Sponsors
Randomized controlled trial to Assess Immunoglobulin plus Steroid Efficacy for Kawasaki disease (RAISE) Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Kawasaki disease patients with risk score 5 points or more. 2. Kawasaki disease patients whose written informed consent has been obtained (from them or from their parents). 3. The following Kawasaki disease mimicking diseases will be clinically ruled out: streptococcus, Epstain-Bar virus, adenovirus, or yersinia infection, or measles, or Stevens-Johnson syndrome.
Exclusion criteria
Exclusion criteria: 1. Patients without informed consent to participate in this study. 2. Patients with past histories of Kawasaki disease (recurrent cases). 3. Patients diagnosed on the ninth day of illness or later (the first illness day is defined as the day when the patient develops a fever). 4. Kawasaki disease patients with coronary lesions before starting treatment. 5. Kawasaki disease patients being afebrile before starting treatment. 6. Patients having received steroids (oral, intravenous, intramuscular, or subcutaneous) within a month. 7. Patients having received intravenous immune gamma-globulin infusion. 8. Patients with the following severe diseases: immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases, etc. 9. Patients with the following active bacterial infections: sepsis, septic meningitis, peritonitis, bacterial pneumonia, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of coronary artery lesions until 1 month after initial treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of coronary lesions at 1 month after initial treatment, incidence of resistance to initial treatment or relapse, number of days until becoming afebrile, serum levels of C-reactive protein at 1 and 2 weeks after starting treatment, and adverse events. | — |
Countries
Japan
Contacts
Public ContactTohru Kobayashi
Gunma University Grraduate School of Medicine Department of Pediatrics
Outcome results
None listed