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

项目摘要 美国每年新增莱姆病病例超过30万例，大约一半的新病例 发生在儿童身上。儿童莱姆病脑膜炎，莱姆病的临床表现，目前与 头痛、发烧和疲劳。以前，首先推荐静脉注射抗生素（头孢曲松） 治疗莱姆病脑膜炎，但它与高并发症率有关，无论是长期的， 长期静脉导管放置药物输送或并发症从药物本身。基于 欧洲在成人中进行的试验和小型观察性儿科研究，一些临床医生已经开始 用口服抗生素（强力霉素）治疗儿童莱姆病脑膜炎，避免相关并发症 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病脑膜炎的效果， 重点是短期恢复和长期生活质量。我们的第二个目标是检查病人， 父母和临床医生的偏好，以告知有关莱姆病脑膜炎治疗的共同决策。 为了实现我们的目标，我们提出了一项全面的儿童莱姆病脑膜炎研究，招募儿童， 20个美国中心位于莱姆病流行的美国地区。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，以跟踪结果 在接下来的六个月里。我们将招募总共210名患有莱姆病脑膜炎的儿童，以确定 口服强力霉素治疗儿童莱姆病的疗效不亚于静脉注射头孢曲松。我们 将采访患者，父母和临床医生，以获得对形成因素的细致入微的理解， 治疗决定。这项研究的总体影响将是为治疗以下疾病的最佳实践提供信息： 儿童莱姆病脑膜炎占关键利益相关者的偏好。

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.