CEFTRIAXONE & DOXYCYCLINE IN PATIENTS WITH SEROPOSITIVE CHRONIC POST LYME DISEASE

头孢曲松

• 批准号: 6275705
• 负责人: Mark S Klempner
• 金额: $ 4.05万
• 依托单位: TUFTS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6275705
• 关键词: Lyme disease; antibacterial agents; case history; cephalosporins; chronic disease /disorder; clinical research; clinical trials; drug screening /evaluation; human subject; human therapy evaluation; intravenous administration; microorganism disease chemotherapy; neuropsychological tests; oral administration; quality of life; tetracyclines

These studies will explore treatment strategies for chronic Lyme disease and will be conducted at two centers, New England Medical Center/Tufts University School of Medicine and Westchester County Medical Center affiliated with New York Medical College. The coordinating center, and the central laboratory facility will be at New England Medical Center. Investigators will perform an initial assessment of each patient for collection of demographic data, a history of exposure to ticks in geographic regions with endemic B. burgdorferi infection, clinical manifestations of acute Lyme disease, clinical manifestations of chronic Lyme disease, and prior treatment. History and physical examination will include evaluation of tender points, detailed neurologic examination and neuropsychological testing. Subjects will receive intravenous therapy at home consisting of ceftriaxone at a dose of 2 grams daily or intravenous placebo (dextrose) for the first 30 days of the treatment period followed by doxycycline 100 mg bid orally (or placebo) for 60 consecutive days. Patients will be measured at baseline, three months (at the end of treatment) and at six months. Due to the absence of specific markers for chronic Lyme disease, outcomes will be assessed based upon measurement of the subject's physical and neuropsychological well being. The primary outcome for this study is defined as an improvement in the patients' health-related quality of life (HQL). Health-related quality of life will be measured using the SF-36 Health Survey.

这些研究将探索慢性莱姆病的治疗策略 并将在新英格兰医疗中心/塔夫茨的两个中心进行 大学医学院和威彻斯特县医疗中心 隶属于纽约医学院。 协调中心，以及 中央实验室设施将在新英格兰医疗中心。 调查人员将对每个患者进行初步评估 收集人口统计数据，暴露于tick的历史 具有特有B. burgdorferi感染的地理区域，临床 急性莱姆病的表现，慢性的临床表现 莱姆病和先前的治疗。 历史和体格检查将 包括评估招标点，详细的神经检查和 神经心理学测试。 受试者将接受静脉治疗 每天或静脉注射2克的头孢曲松组成的房屋 安慰剂（葡萄糖）在治疗期的前30天之后 连续60天通过多西环素100 mg口服（或安慰剂）。 将在基线时（三个月结束时）测量患者 治疗）和六个月。 由于没有特定标记 慢性莱姆病，将根据测量结果评估结果 受试者的身体和神经心理学健康。 主要 这项研究的结果定义为患者的改善 与健康相关的生活质量（HQL）。 与健康相关的生活质量将使用SF-36健康衡量 民意调查。