Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary artery aneurysms in Kawasaki disease
Kawasaki Disease Coronary Artery Aneurysm Prevention trial
What is this study about?
In the KD-CAAP trial, we aim to answer whether adding immediate corticosteroid treatment to standard of care IVIG and aspirin will reduce coronary artery aneurysm (CAA) rates in unselected KD patients across Europe compared with IVIG and aspirin alone.
Type of study
Who is funding the study?
Innovative Medicines Initiative 2 Joint Undertaking (JU) that supports the conect4children (c4c) research consortium
PPI through Societi (https://www.societi.org.uk/)
When is it taking place?
May 2019 - December 2023
Where is it taking place?
The trial is run from 59 hospitals across the Austria, Belgium, Czech Republic, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Spain, Sweden and UK
Who is included?
Children who aged between 30 days and 15 years who are diagnosed with Kawasaki Disease through a set of clinical criteria or clinical criteria and laboratory assessments.