KD-CAAP v1.0
Research type
Research Study
Full title
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 (KD-CAAP: Kawasaki Disease Coronary Artery Aneurysm Prevention trial)
IRAS ID
272055
Contact name
Despina Eleftheriou
Contact email
Sponsor organisation
MRC CTU at UCL
Eudract number
2019-004433-17
Duration of Study in the UK
3 years, 8 months, 1 days
Research summary
This study will work out the best way to treat children and adolescents aged between 30 days and 15 years who have Kawasaki disease. 262 children/adolescents with Kawasaki disease will be recruited from hospitals across 15 European countries. Kawasaki disease is a disease where arteries, particularly the coronary arteries in the heart, become inflamed, sometimes causing irreversible heart damage, heart attacks or even death.
The current standard treatment for Kawasaki disease is intravenous immunoglobulin(IVIG) and aspirin. Many children and adolescents still develop significant heart damage despite IVIG. In the UK, heart damage has been found in 19% of cases despite IVIG; in other countries it is as high as 42%. In this study corticosteroids will be added to standard treatment to determine whether this combination reduces the rate of heart complications in children/adolescents. Corticosteroids have been used for many years to treat similar inflammatory conditions, but are not yet widely used as an initial treatment for Kawasaki disease.
Following randomisation children/adolescents will be followed-up for 12 weeks through face-to-face visits – they will mostly stay in hospital for the first 5-7 days, after which there is three visits. This duration of follow-up is standard for routine clinical care of Kawasaki disease. The visits will particularly focus on
- looking for any damage to their coronary arteries (or other heart damage) using heart ultrasound (echocardiography) scans;
- whether they experienced any side effects from the medicines they received;
- whether they needed to receive any additional treatments; how long they had to stay in hospital;
- whether they have to be admitted to hospital again;
- how rapidly their blood tests normalised;
- how much all their care costs; and
- if our treatments overall improve their quality of life.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
20/NE/0014
Date of REC Opinion
18 Feb 2020
REC opinion
Further Information Favourable Opinion