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

静脉注射头孢曲松与口服多西环素治疗莱姆脑膜炎的疗效和并发症比较

• 批准号: 10210893
• 负责人: Aris C Garro
• 金额: $ 13.79万
• 依托单位: RHODE ISLAND HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10210893
• 关键词: Accounting; Address; Adult; Affect; Aftercare; Antibiotics; Biometry; Boston; Catheters; Ceftriaxone; Cephalic; Child; Child Care; Childhood; Clinical; Collaborations; Communicable Diseases; Complication; Data Coordinating Center; Diagnosis; Doxycycline; Enrollment; Equipment and supply inventories; Europe; European; Fatigue; Fever; Goals; Grant; Guidelines; Headache; Health Care Costs; Informed Consent; Institutional Review Boards; Interview; Intravenous; Knowledge; Lyme Disease; Measurement; Medicine; Meningitis; Methods; Neuritis; Neurologic; Neurologic Symptoms; Observational Study; Oral; Outcome; Parents; Patient-Centered Care; Patients; Pediatric Hospitals; Pharmaceutical Preparations; Qualitative Methods; Quality of life; Recovery; Research; Resolution; Risk; Shapes; Surveys; Symptoms; Time; Treatment Effectiveness; Universities; Update; Utah; Work; base; clinical practice; comparative effectiveness; comparative effectiveness study; cost; design; disease diagnosis; experience; improved; innovation; instrument; multidisciplinary; preference; prospective; recruit; shared decision making; side effect; success

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.

项目概要 美国每年新增莱姆病病例超过 30 万例，其中约一半是新增病例 发生于儿童。患有莱姆脑膜炎（莱姆病的一种临床表现）的儿童会出现 头痛、发烧和疲劳。此前，首先推荐静脉注射抗生素（头孢曲松） 莱姆脑膜炎的治疗方法，但它与长期相关的并发症发生率很高有关。 术语静脉导管放置用于药物输送或药物本身引起的并发症。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 使用口服抗生素（强力霉素）治疗儿童莱姆脑膜炎，避免相关并发症 静脉注射头孢曲松并降低医疗费用。 我们的第一个目标是比较口服多西环素与静脉注射头孢曲松治疗莱姆脑膜炎的效果， 注重短期康复和长期生活质量。我们的第二个目标是检查病人， 家长和临床医生的偏好，为有关莱姆脑膜炎治疗的共同决策提供信息。 为了实现我们的目标，我们提议开展一项全面的儿科莱姆脑膜炎研究，招募以下儿童： 20 个美国中心位于美国莱姆病流行地区。治疗决定将是 由孩子的医生按照惯例做出，我们将获得知情同意以跟踪结果 在接下来的六个月里。我们将总共招募 210 名患有莱姆脑膜炎的儿童来确定是否 口服多西环素治疗儿童莱姆脑膜炎的效果并不逊色于静脉注射头孢曲松。我们 将采访患者、家长和临床医生，以深入了解影响健康的因素 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 患有莱姆脑膜炎的儿童考虑了关键利益相关者的偏好。