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.
Subject(s)
Fever/drug therapy , Immunoglobulins, Intravenous/therapeutic use , Infliximab/therapeutic use , Mucocutaneous Lymph Node Syndrome/drug therapy , Adolescent , Child , Child, Preschool , Comparative Effectiveness Research , Cross-Over Studies , Drug Resistance , Echocardiography , Female , Fever/etiology , Humans , Immunoglobulins, Intravenous/administration & dosage , Immunoglobulins, Intravenous/adverse effects , Infant , Inflammation Mediators/analysis , Infliximab/administration & dosage , Infliximab/adverse effects , Length of Stay , Male , Mucocutaneous Lymph Node Syndrome/complicationsABSTRACT
Acrodynia is a reaction that occurs in children who have been exposed to mercury. Mercury toxicity has systemic manifestations as well as cutaneous manifestations, which can appear similar to those found in a number of other diseases. We present a case of acrodynia caused by mercury exposure in a previously healthy 5-year-old girl who developed hypertension, palmoplantar pruritus, and a papulovesicular eruption.
