Comparative effectiveness and complications of intravenous ceftriaxone compared with oral doxycycline in Lyme meningitis

项目总结 随着美国每年新增30多万莱姆病病例，大约一半的新病例 发生在儿童身上。莱姆病的临床表现--莱姆氏脑膜炎的儿童 头痛、发烧和疲劳。在此之前，首先推荐静脉注射抗生素(头孢曲松)。 治疗莱姆氏脑膜炎，但它与高并发症有关，要么与长期- 用于药物输送或药物本身并发症的长期静脉导管。基于 在欧洲进行的成人试验和小儿科观察性研究中，一些临床医生已经开始 口服抗生素(多西环素)治疗儿童莱姆脑膜炎，避免相关并发症 配合静脉注射头孢曲松，降低医疗费用。 我们的第一个目标是比较口服多西环素和静脉注射头孢曲松治疗莱姆氏脑膜炎， 既注重短期恢复，又注重长期生活质量。我们的第二个目标是检查病人， 家长和临床医生的偏好，以告知关于莱姆脑膜炎治疗的共同决策。 为了实现我们的目标，我们建议进行一项全面的儿科莱姆脑膜炎研究，在以下位置招募儿童 位于莱姆病流行地区的20个美国中心。治疗决定将是 由孩子的医生按照惯例进行，我们将获得知情同意来跟踪结果 在接下来的六个月里。我们将招募210名患有莱姆氏脑膜炎的儿童，以确定 口服多西环素治疗儿童莱姆脑炎疗效不逊于静脉注射头孢曲松。我们 将采访患者、父母和临床医生，以获得对形成这些因素的细微差别的了解 治疗决定。这项研究的总体影响将是提供治疗该病的最佳做法 莱姆脑膜炎儿童占主要利益相关者的偏好。

PROJECT SUMMARY With more than 300,000 new cases of Lyme disease each year in the U.S., approximately half of new cases occur in children. Children with Lyme meningitis, a clinical manifestation of Lyme disease, present with headache, fever and fatigue. Previously, an intravenous antibiotic (ceftriaxone) was the recommended first treatment for Lyme meningitis, but it is associated with a high rate of complications related either to the long- term intravenous catheter placed for medication delivery or to complications from the medicine itself. Based on European trials conducted in adults and small observational pediatric studies, some clinicians have begun treating Lyme meningitis in children with an oral antibiotic (doxycycline), avoiding the complications associated with intravenous ceftriaxone and reducing health care costs. Our first goal is to compare oral doxycycline to intravenous ceftriaxone for the treatment of Lyme meningitis, with a focus on both short-term recovery and long-term quality of life. Our second goal is to examine patient, parent and clinician preferences to inform shared decision-making about Lyme meningitis treatments. To accomplish our goals, we propose a comprehensive pediatric Lyme meningitis study, enrolling children at 20 U.S. centers located in regions of the U.S. where Lyme disease is endemic. Treatment decisions will be made by the child’s doctors, per usual practice, and we will obtain informed consent to follow the outcomes over the following six months. We will enroll a total of 210 children with Lyme meningitis to determine whether oral doxycycline is not inferior to intravenous ceftriaxone for the treatment of Lyme meningitis in children. We will interview patients, parents and clinicians to gain a nuanced understanding of the factors that shape treatment decisions. The overall impact of this study will be to inform the best practices for the treatment of children with Lyme meningitis accounting for the preferences of key stake holders.