Browsing by Author "El Feghaly, Rana"

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    The Kawasaki Disease Comparative Effectiveness (KIDCARE) trial: A phase III, randomized trial of second intravenous immunoglobulin versus infliximab for resistant Kawasaki disease
    (Elsevier, 2019-04) Roberts, Samantha C.; Jain, Sonia; Tremoulet, Adriana H.; Kim, Katherine K.; Burns, Jane C.; Anand, Vikram; Anderson, Marsha; Ang, Jocelyn; Ansusinha, Emily; Arditi, Moshe; Ashouri, Negar; Bartlett, Allison; Chatterjee, Archana; DeBiasi, Roberta; Dekker, Cornelia; DeZure, Chandani; Didion, Lisa; Dominguez, Samuel; El Feghaly, Rana; Erdem, Guliz; Halasa, Natasha; Harahsheh, Ashraf; Jackson, Mary Anne; Jaggi, Preeti; Jain, Supriya; Jone, Pei-Ni; Kaushik, Neeru; Kurio, Gregory; Lillian, Anna; Lloyd, David; Manaloor, John; McNelis, Amy; Michalik, David E.; Newburger, Jane; Newcomer, Charles; Perkins, Tiffany; Portman, Michael; Romero, Jose; Ronis, Tova; Rowley, Anne; Schneider, Kathryn; Schuster, Jennifer; Sexson Tejtel, S. Kristen; Sharma, Kavita; Simonsen, Kari; Szmuszkovicz, Jacqueline; Truong, Dongngan; Wood, James; Yeh, Sylvia; Pediatrics, School of Medicine
    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.