Evaluation of the usefulness of a new protocol (Shizuoka protocol 2011) for the treatment of Kawasaki disease

Not Applicable

• Conditions: Kawasaki disease

• Registration Number: JPRN-UMIN000012741
• Lead Sponsor: Shizuoka Children's Hospital, Department of Allergy and Clinical Immunology

Brief Summary

Background: Prednisolone (PSL) has been suggested to be useful for the treatment of patients with Kawasaki disease (KD) resistant to intravenous immunoglobulin (IVIG). However, much remains to be elucidated regarding its proper use. Methods: Two-stage multicenter prospective studies involving 1,087 subjects were performed to study the effects of acute phase therapy on IVIG-resistant KD. Subjects resistant to the first dose of IVIG were classified into high (>=10 mg/dL) and low (< 10 mg/dL) CRP groups according to serum CRP levels after the first dose of IVIG. Results: In the first study, the effect of the second dose of IVIG in the high CRP group was significantly lower than that in the low CRP group (47.8 vs. 76.8%, p < 0.005). In the second study, PSL was co-administered with the second dose of IVIG to patients of the high CRP group (intensified regimen). The efficacy of the intensified regimen was comparable to that of the second dose of IVIG in the low CRP group (79.4 vs. 83.3%). Although the difference in the incidence of persistent coronary artery lesion (CAL) between the high and low CRP groups was significant in the first study (19.6 vs. 3.0%, p < 0.005), it was not significant in the second study (8.8 vs. 2.4%). Conclusions: This study suggests the effectiveness of targeted use of PSL with the second dose of IVIG to KD patients who are resistant to the first dose of IVIG and are predicted to be resistant to the second dose of IVIG.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-01
• Study Completion: 2015-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Kawasaki disease diagnostic criteria less than 4/6

Study & Design

• Study Type: Interventional
• Study Design: Not specified