Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy of the addition of prednisolone to conventional initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in reducing coronary artery lesion in children with Kawasaki disease (KD) .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Collaborators: Beijing Children's Hospital; Chengdu Women's and Children's Central Hospital; Children's Hospital of Chongqing Medical University; Children's Hospital Of Soochow University; First People's Hospital of Hangzhou; Inner Mongolia People's Hospital; Jiangxi Province Children's Hospital; Qilu Hospital of Shandong University; Shengjing Hospital; Sichuan Provincial People's Hospital; The First Hospital of Jilin University; Third Affiliated Hospital of Zhengzhou University; Wuhan Union Hospital, China; Yuying Children's Hospital of Wenzhou Medical University
• Treatments: Aspirin; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2017

• Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)

• Not treated with IVIG yet

• Age ≥1 month

Exclusion Criteria:

• Z score of any coronary artery before initial treatment ≥10

• Receiving steroids or other immunosuppressive agents in the previous 30 days

• With a previous history of KD

• Afebrile before enrolment

• With suspected infectious diseases including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella and influenza

• With serious immune diseases such as immunodeficiency or chromosomal abnormalities