Status:
ACTIVE_NOT_RECRUITING
Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease
Lead Sponsor:
Children's Hospital of Fudan University
Collaborating Sponsors:
Jiangxi Province Children's Hospital
First People's Hospital of Hangzhou
Conditions:
Kawasaki Disease
Eligibility:
All Genders
1+ years
Phase:
PHASE3
Brief 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 wi...
Detailed Description
This is a multicenter, open-label, blind-endpoints, randomized controlled trial at more than 10 hospitals in China. The investigators enrolled KD children diagnosed within 10 days of onset. Participan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
3208 Patients enrolled
Trial Details
Trial ID
NCT04078568
Start Date
January 15 2020
End Date
December 31 2025
Last Update
December 30 2025
Active Locations (34)
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1
Bengbu First People's Hopital
Bengbu, Anhui, China, 233000
2
Anhui Children's Hospital
Hefei, Anhui, China, 230022
3
Children's Hospital, Capital Institute of Pediatrics
Beijing, Beijing Municipality, China, 100020
4
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400014