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ELEFTHERIOU, Despina, MORAES, Yolanda Collaco, PURVIS, Cara, PURSELL, Molly, MORILLAS, Marta Merida, KAHN, Robin, MOSSBERG, Maria, KUCERA, Filip, TULLOH, Robert, STANDING, Joseph F., SWALLOW, Veronica, MCCORMACK, Rachael, HERBERG, Jethro, LEVIN, Michael, WAN, Mandy, KLEIN, Nigel, CONNON, Roisin, WALKER, Ann Sarah and BROGAN, Paul (2023). 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. Trials, 24 (1).
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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. 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. 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. Trial registration: ISRCTN71987471- March 31, 2020; Eudract 2019–004433-17.
| Item Type: | Article |
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| Additional Information: | ** From Springer Nature via Jisc Publications Router ** Licence for this article: http://creativecommons.org/licenses/by/4.0/ ** Acknowledgements: Acknowledgements: We acknowledge input from the conect4children network. All families and patients participating in KD-CAAP. **Journal IDs: eissn 1745-6215 **Article IDs: publisher-id: s13063-022-07051-9; manuscript: 7051 **History: collection 12-2023; online 26-01-2023; published 26-01-2023; accepted 23-12-2022; registration 23-12-2022; submitted 28-10-2022 |
| Uncontrolled Keywords: | Study Protocol, Kawasaki disease, Corticosteroids, Coronary artery aneurysms |
| Identification Number: | https://doi.org/10.1186/s13063-022-07051-9 |
| SWORD Depositor: | Colin Knott |
| Depositing User: | Colin Knott |
| Date Deposited: | 30 Jan 2023 10:37 |
| Last Modified: | 24 Apr 2024 08:01 |
| URI: | https://shura.shu.ac.uk/id/eprint/31339 |
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