The Kawasaki Disease Comparative Effectiveness (KIDCARE) trial: A phase III, randomized trial of second intravenous immunoglobulin versus infliximab for resistant Kawasaki disease.

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 ≥36 h after the completion of their first IVIG treatment. Eligible patients will be randomized to receive either a second dose of IVIG (2 g/kg) or infliximab (10 mg/kg). Subjects with persistent or recrudescent fever at 24 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 (5-18 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.

• Authors: Samantha C Roberts, Sonia Jain, Adriana H Tremoulet, Katherine K Kim, Jane C Burns, KIDCARE Multicenter Study Group, Vikram Anand, Marsha Anderson, Jocelyn Ang, Emily Ansusinha, Moshe Arditi, Negar Ashouri, Allison Bartlett, Archana Chatterjee, Roberta DeBiasi, Cornelia Dekker, Chandani DeZure, Lisa Didion, Samuel Dominguez, Rana El Feghaly, Guliz Erdem, Natasha Halasa, Ashraf Harahsheh, Mary Anne Jackson, Preeti Jaggi, Supriya Jain, Pei-Ni Jone, Neeru Kaushik, Gregory Kurio, Anna Lillian, David Lloyd, John Manaloor, Amy McNelis, David E Michalik, Jane Newburger, Charles Newcomer, Tiffany Perkins, Michael Portman, Jose Romero, Tova Ronis, Anne Rowley, Kathryn Schneider, Jennifer Schuster, S Kristen Sexson Tejtel, Kavita Sharma, Kari Simonsen, Jacqueline Szmuszkovicz, Dongngan Truong, James Wood, Sylvia Yeh
• Journal: Contemporary clinical trials (Contemp Clin Trials) Vol. 79 Pg. 98-103 (04 2019) ISSN: 1559-2030 [Electronic] United States
• PMID: 30840903 (Publication Type: Clinical Trial Protocol, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019 Elsevier Inc. All rights reserved.

Chemical References

• Immunoglobulins, Intravenous
• Inflammation Mediators
• Infliximab

Topics

• Adolescent
• Child
• Child, Preschool
• Comparative Effectiveness Research
• Cross-Over Studies
• Drug Resistance
• Echocardiography
• Female
• Fever (drug therapy, etiology)
• Humans
• Immunoglobulins, Intravenous (administration & dosage, adverse effects, therapeutic use)
• Infant
• Inflammation Mediators (analysis)
• Infliximab (administration & dosage, adverse effects, therapeutic use)
• Length of Stay
• Male
• Mucocutaneous Lymph Node Syndrome (complications, drug therapy)