TY - JOUR
T1 - The Kawasaki Disease Comparative Effectiveness (KIDCARE) trial
T2 - A phase III, randomized trial of second intravenous immunoglobulin versus infliximab for resistant Kawasaki disease
AU - KIDCARE Multicenter Study Group
AU - Roberts, Samantha C.
AU - Jain, Sonia
AU - Tremoulet, Adriana H.
AU - Kim, Katherine K.
AU - Burns, Jane C.
AU - Anand, Vikram
AU - Anderson, Marsha
AU - Ang, Jocelyn
AU - Ansusinha, Emily
AU - Arditi, Moshe
AU - Ashouri, Negar
AU - Bartlett, Allison
AU - Chatterjee, Archana
AU - DeBiasi, Roberta
AU - Dekker, Cornelia
AU - DeZure, Chandani
AU - Didion, Lisa
AU - Dominguez, Samuel
AU - El Feghaly, Rana
AU - Erdem, Guliz
AU - Halasa, Natasha
AU - Harahsheh, Ashraf
AU - Jackson, Mary Anne
AU - Jaggi, Preeti
AU - Jain, Supriya
AU - Jone, Pei Ni
AU - Kaushik, Neeru
AU - Kurio, Gregory
AU - Lillian, Anna
AU - Lloyd, David
AU - Manaloor, John
AU - McNelis, Amy
AU - Michalik, David E.
AU - Newburger, Jane
AU - Newcomer, Charles
AU - Perkins, Tiffany
AU - Portman, Michael
AU - Romero, Jose
AU - Ronis, Tova
AU - Rowley, Anne
AU - Schneider, Kathryn
AU - Schuster, Jennifer
AU - Tejtel, S. Kristen Sexson
AU - Sharma, Kavita
AU - Simonsen, Kari
AU - Szmuszkovicz, Jacqueline
AU - Truong, Dongngan
AU - Wood, James
AU - Yeh, Sylvia
N1 - Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2019/4
Y1 - 2019/4
N2 - 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.
AB - 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.
KW - IVIG
KW - IVIG-resistance
KW - Infliximab
KW - Kawasaki disease
UR - http://www.scopus.com/inward/record.url?scp=85062835937&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85062835937&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2019.02.008
DO - 10.1016/j.cct.2019.02.008
M3 - Article
C2 - 30840903
AN - SCOPUS:85062835937
SN - 1551-7144
VL - 79
SP - 98
EP - 103
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
ER -