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 并将在两个中心进行：新英格兰医学中心/塔夫茨 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 中心实验室设施将位于新英格兰医学中心。 研究人员将对每位患者进行初步评估 收集人口统计数据、接触蜱虫的历史 伯氏疏螺旋体感染流行的地理区域，临床 急性莱姆病的表现、慢性莱姆病的临床表现 莱姆病和先前的治疗。 病史和体格检查将 包括压痛点评估、详细的神经系统检查和 神经心理学测试。 受试者将在以下时间接受静脉治疗 家庭含头孢曲松，剂量为每日 2 克或静脉注射 随后治疗期的前 30 天使用安慰剂（葡萄糖） 连续 60 天口服强力霉素 100 mg bid（或安慰剂）。 患者将在基线、三个月（治疗结束时）进行测量 治疗）和六个月时。 由于缺乏特定标记 慢性莱姆病，结果将根据以下测量进行评估 受试者的身体和神经心理健康状况。 初级 这项研究的结果被定义为患者的改善 健康相关的生活质量（HQL）。 将使用 SF-36 Health 来衡量与健康相关的生活质量 民意调查。