The Kawasaki Disease Comparative Effectiveness (KIDCARE) trial: A phase III, randomized trial of second intravenous immunoglobulin versus infliximab for resistant Kawasaki disease.
Contemp Clin Trials
; 79: 98-103, 2019 04.
Article
em En
| MEDLINE
| ID: mdl-30840903
ABSTRACT
BACKGROUND:
Although intravenous immunoglobulin (IVIG) is effective therapy for Kawasaki disease (KD), the most common cause of acquired heart disease in children, 10-20% of patients are IVIG-resistant and require additional therapy. This group has an increased risk of coronary artery aneurysms (CAA) and there has been no adequately powered, randomized clinical trial in a multi-ethnic population to determine the optimal therapy for IVIG-resistant patients.OBJECTIVES:
The primary outcome is duration of fever in IVIG-resistant patients randomized to treatment with either infliximab or a second IVIG infusion. Secondary outcomes include comparison of inflammatory markers, duration of hospitalization, and coronary artery outcome. An exploratory aim records parent-reported outcomes including signs, symptoms and treatment experience.METHODS:
The KIDCARE trial is a 30-site randomized Phase III comparative effectiveness trial in KD patients with fever ≥36â¯h after the completion of their first IVIG treatment. Eligible patients will be randomized to receive either a second dose of IVIG (2â¯g/kg) or infliximab (10â¯mg/kg). Subjects with persistent or recrudescent fever at 24â¯h following completion of the first study treatment will cross-over to the other treatment arm. Subjects will exit the study after their first outpatient visit (5-18â¯days following last study treatment). The parent-reported outcomes, collected daily during hospitalization and at home, will be compared by study arm.CONCLUSION:
This trial will contribute to the management of IVIG-resistant patients by establishing the relative efficacy of a second dose of IVIG compared to infliximab and will provide data regarding the patient/parent experience of these treatments.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Imunoglobulinas Intravenosas
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Febre
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Infliximab
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Síndrome de Linfonodos Mucocutâneos
Tipo de estudo:
Clinical_trials
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Etiology_studies
Limite:
Adolescent
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Child
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Child, preschool
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Female
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Humans
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Infant
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Male
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article