Randomized controlled trial to Assess Immunoglobulin plus Steroid Efficacy for Kawasaki disease

Phase 3

• Conditions: Kawasaki disease

• Registration Number: JPRN-UMIN000000940
• Lead Sponsor: Randomized controlled trial to Assess Immunoglobulin plus Steroid Efficacy for Kawasaki disease (RAISE) Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-27
• Study Completion: 2011-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 392

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified