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临床试验/NCT03958058
NCT03958058已完成不适用

Tick-Borne Encephalitis Virus and Lyme Borreliae Causing Coillness, Coinfection, or Just Coincidence. A Prospective Observational Study

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 690 人开始时间: 2007年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
690
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 Europe, tick-borne encephalitis (TBE) virus causing TBE is transmitted by the bite of Ixodes ricinus tick, which can also transmit Lyme borreliae , the causative agent of Lyme borreliosis (LB). Since TBE and LB are both endemic with high incidence rates in Slovenia, we should be attentive to the possibility of double infections. Double infections with TBE virus and Lyme borreliae were reported to occur rarely even in endemic countries, however reliable data on coinfection rates are rather limited. Microbiological diagnosis of TBE virus infection is quite straightforward, and there is no specific therapy for TBE available so far. This markedly differs from borrelial infection, in which case interpretation of serological test results demands more caution, but there is highly efficient antibiotic treatment available for LB. This may lead to over prescribing of antibiotics to TBE patients with documented borrelial antibodies in serum indicating possible coinfection with Lyme borreliae, but missing clinical or microbiological criteria for proven borrelial coinfection. Approximately 10% of patients who had been treated appropriately for LB and about one third of patients after TBE report nonspecific subjective complaints, such as fatigue, headache, arthralgia, and myalgia, termed post-Lyme and post-encephalitic symptoms, respectively. These may not be differentiated clearly from nonspecific symptoms occurring with a rather substantial incidence also in the general population. A trend of ascribing medically unexplained nonspecific subjective symptoms to LB in subjects with positive borrelial antibodies in serum puzzles the situation further.

The aim of this prospective observational study was to assess the proportion and clinical implication of proven and possible coinfection with Lyme borreliae in patients with TBE, and to evaluate the association between anti-borrelial antibiotic therapy and clinical outcome in the subgroup of patients with possible coinfection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥18 years
  • admitted between January 2007 and December 2013 at the University Medical Centre Ljubljana, Slovenia
  • tick-borne encephalitis defined according to European criteria (febrile illness with symptoms and/or signs of meningitis or meningoencephalitis, cerebrospinal fluid (CSF) pleocytosis (>5 × 106 cells/L), and demonstration of acute TBE virus infection (the presence of specific tick-borne encephalitis virus IgM and IgG antibodies in serum or demonstration of intrathecal production of specific TBE virus IgM and/or IgG antibodies in patients previously vaccinated against tick-borne encephalitis)

排除标准

  • Lyme borreliosis in the past

研究组 & 干预措施

Anti-borrelial antibiotic therapy

干预措施: Anti-borrelial antibiotic therapy (Drug)

No antibiotics

Patients who received symptomatic therapy (paracetamol, Lekadol®, granisetron, Kytril®, metamizol, Analgin®, parenteral hydration with saline). Patients reported the presence of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.

干预措施: No antibiotic. (Other)

结局指标

主要结局

Number of patients with objective manifestations of Lyme borreliosis

时间窗: up to 12 months follow-up

At each visit physical examination was performed and clinical signs indicating objective manifestations of Lyme borreliosis, such as erythema migrans, were searched for and documented.

Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia

时间窗: up to 12 months follow-up

At each visit patients were asked to report the presence of nonspecific symptoms.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daša Stupica

Prinicipal Investigator

University Medical Centre Ljubljana

研究点 (1)

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