What is KD-CAAP?
KD-CAAP is a multi-centre, randomised trial of corticosteroids plus standard of care treatment versus standard of care treatment alone to prevent heart complications in Kawasaki disease. The trial is sponsored by University College London and is managed by the Medical Research Council (MRC) Clinical Trials Unit (KD-CAAP Co-ordinating Centre). KD-CAAP will recruit 262 participants across 13 European Countries.
This study will work out whether corticosteroids plus standard treatment are better than standard treatment alone to treat children and adolescents aged between 30 days and 15 years who have Kawasaki disease.
What is Kawasaki Disease?
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. Kawasaki disease is currently the most common cause of acquired heart disease in childhood, and an important preventable cause of heart disease in the young. These heart complications may occur within a few weeks of getting the disease, or more typically, some years after recovery due to narrowing of the coronary arteries causing lack of blood supply to the heart.
To prevent this heart damage, Kawasaki disease in children and young people has to be recognised by clinicians early, and promptly treated with anti-inflammatory medicines.
Why is this study needed?
The problem is that Kawasaki disease presents with a range of symptoms that are common in normal childhood infections, including high fever, rash, bloodshot eyes, “strawberry” red tongue, cracked, dry lips, swollen lymph glands in the neck, and redness and swelling of the palms and soles. No one knows what causes Kawasaki disease, and this is an area of ongoing and intense research around the world.
The standard treatment for Kawasaki disease is Intravenous immunoglobulin (IVIG) and aspirin. IVIG is a blood product derived from many different pooled healthy blood donors, containing antibodies naturally produced by the immune system. IVIG is the standard treatment given in Kawasaki disease to “dampen down” inflammatory processes which occur in the first few days of the illness.
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%. Corticosteroids (‘steroids’) have been used for decades to treat similar inflammatory conditions but are not yet widely used as an initial treatment for Kawasaki disease.
What will the study tell us that is new?
KD-CAAP will tell us whether giving corticosteroids upfront (in addition to IVIG and aspirin) to children and adolescents with Kawasaki disease across Europe reduces the high rate of heart complications.
Interested in this study? You can find out more on the KD-CAAP website.