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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 (CAA) in Kawasaki disease (KD): the KD CAA prevention (KD-CAAP) trial protocol.
- Source :
-
Trials [Trials] 2023 Jan 26; Vol. 24 (1), pp. 60. Date of Electronic Publication: 2023 Jan 26. - Publication Year :
- 2023
-
Abstract
- Background: Kawasaki disease (KD) is an acute self-limiting inflammatory vasculitis affecting predominantly medium-sized arteries, particularly the coronary arteries. A number of recent studies conducted in different European countries have demonstrated alarmingly high coronary complications despite treatment with intravenous immunoglobulin (IVIG). These high complication rates now emphasize the need for an urgent reappraisal of IVIG as the sole primary therapeutic agent for KD. The Kawasaki disease CAA prevention (KD-CAAP) trial will test the hypothesis that immediate adjunctive corticosteroid treatment to standard of care IVIG and aspirin will reduce coronary artery aneurysm (CAA) rates in unselected KD patients across Europe.<br />Methods: KD-CAAP is a multicentre, randomised, controlled, open-label, blinded endpoint assessed trial that will be conducted across Europe supported by the conect4children pan-European clinical trials network. Patients with KD who satisfy the eligibility criteria will be randomised (1:1) to receive either oral prednisolone 2 mg/kg/day plus standard of care therapy IVIG (2 g/kg) and aspirin (40 mg/kg/day); or IVIG and aspirin alone. Further management is dictated by temperature and C-reactive protein (CRP) responses. Co-primary outcomes are as follows: (i) any CAA within the 3 months of trial follow-up; (ii) average estimate of maximum coronary Z-score at weeks 1, 2 and 6 adjusting for rescue treatment. Additional outcomes will be assessed including cost effectiveness, quality of life, corticosteroid toxicity and other safety outcomes.<br />Discussion: Several recent studies have indicated that coronary complications associated with KD across Europe are much higher than early trials of IVIG had initially suggested. KD-CAAP directly addresses this issue by exploring the therapeutic benefit of adjunctive corticosteroids in unselected KD cases. If we find that corticosteroids prevent CAA and are safe, this is a cheap and widely available intervention that could be implemented immediately for the benefit of children.<br />Trial Registration: ISRCTN71987471- March 31, 2020; Eudract 2019-004433-17.<br /> (© 2023. The Author(s).)
- Subjects :
- Child
Humans
Infant
Coronary Vessels
Multicenter Studies as Topic
Quality of Life
Randomized Controlled Trials as Topic
Child, Preschool
Adolescent
Adrenal Cortex Hormones adverse effects
Adrenal Cortex Hormones therapeutic use
Aneurysm complications
Aneurysm drug therapy
Aspirin adverse effects
Aspirin therapeutic use
Immunoglobulins, Intravenous adverse effects
Immunoglobulins, Intravenous therapeutic use
Mucocutaneous Lymph Node Syndrome complications
Mucocutaneous Lymph Node Syndrome diagnosis
Mucocutaneous Lymph Node Syndrome drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1745-6215
- Volume :
- 24
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 36703139
- Full Text :
- https://doi.org/10.1186/s13063-022-07051-9