CompletedPhase 3

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

China3,208 participantsStarted 2020-01-15

Plain-language 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) .

Who can participate

Age range1 Month

SexALL

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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

What they're measuring

Percentage of coronary artery lesions(CAL) at one month of illness

Timeframe: at one month of illness

Trial details

NCT IDNCT04078568

SponsorChildren's Hospital of Fudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-30

View on ClinicalTrials.gov More Kawasaki Disease trials