Antibiotic Therapy for Patients With Tick-borne Encephalitis and Borrelial Antibodies in Serum
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of patients with objective manifestations of Lyme borreliosis
研究概览
简要总结
In Slovenia, tick-borne encephalitis and Lyme borreliosis are both endemic diseases with high incidence rates and they are both transmitted by a bite of infected Ixodes ricinus tick. In clinical practice, tick-borne encephalitis is confirmed by demonstration of tick-borne encephalitis antibodies in serum of a patient with compatible clinical presentation and cerebrospinal pleocytosis. Patients with Lyme meningitis or meningoradiculitis also have cerebrospinal pleocytosis, however the presence of borrelial antibodies in serum does not attest Lyme neuroborreliosis. Patients with tick-borne encephalitis and positive borrelial antibodies in serum, but not fulfilling criteria for Lyme neuroborreliosis, are often being treated with antibiotics in several European countries due to the possibility of double infection. The investigators hypothesise that such patients do not benefit from antibiotics. Such an approach may appear safe regarding the possibility of borrelial infection, however it can also be associated with detrimental consequences such as antibiotic related adverse reactions, negative epidemiological impact on bacterial resistance, and intravenous catheter related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •clinical picture compatible with tick-borne encephalitis,
- •clear cerebrospinal fluid,
- •cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid >5 x 106/)L,
- •positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against tick-borne encephalitis virus,
- •positive serum IgG antibodies against Lyme borreliae.
排除标准
- •isolation of B.burgdorferi sensu lato from cerebrospinal fluid,
- •positive intrathecal borrelial antibody production index,
- •seroconversion of borrelial IgG antibodies,
- •presence of erythema migrans and/or borrelial lymphocytoma in the last month,
- •Bannwarth syndrome.
研究组 & 干预措施
Doxycycline, Doxy®
Beside symptomatic therapy, patients will receive oral doxycycline 100 mg (Doxy®) twice daily. Patients will answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
干预措施: Doxycycline (Drug)
Doxycycline, Doxy®
Beside symptomatic therapy, patients will receive oral doxycycline 100 mg (Doxy®) twice daily. Patients will answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
干预措施: Symptomatic therapy (Drug)
Doxycycline, Doxy®
Beside symptomatic therapy, patients will receive oral doxycycline 100 mg (Doxy®) twice daily. Patients will answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
干预措施: Questionnaire (Other)
No antibiotics
Patients will receive symptomatic therapy (paracetamol, Lekadol®, granisetron, Kytril®, metamizol, Analgin®, parenteral hydration with saline). Patients will answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
干预措施: Symptomatic therapy (Drug)
No antibiotics
Patients will receive symptomatic therapy (paracetamol, Lekadol®, granisetron, Kytril®, metamizol, Analgin®, parenteral hydration with saline). Patients will answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
干预措施: Questionnaire (Other)
Healthy controls
Patients will be asked to refer a spouse to serve as a control. If unmarried they will be asked to refer a family member or a friend of +/- 5 years to serve as a control. Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
干预措施: Questionnaire (Other)
结局指标
主要结局
Number of patients with objective manifestations of Lyme borreliosis
时间窗: one year
At each visit physical examination will be performed and clinical signs indicating objective manifestations of Lyme borreliosis, such as erythema migrans, will be searched for.
Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia
时间窗: one year
次要结局
未报告次要终点
研究者
Daša Stupica
Prinicipal Investigator
University Medical Centre Ljubljana