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临床试验/NCT06929546
NCT06929546尚未招募不适用

Anti-phospholipid Antibodies in Adult Patients With Different Clinical Manifestations of Lyme Borreliosis

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年5月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
240
试验地点
1
主要终点
Anti-phospholipid antibody levels in well-defined clinical manifestations of Lyme disease before antibiotic treatment.

研究概览

简要总结

Background Lyme borreliosis, caused by Borrelia burgdorferi sensu lato is transmitted to humans through the bite of an infected Ixodes tick. B. burgdorferi sensu lato accumulates intact phospholipids from its environment to support its growth. Several of these environmentally acquired phospholipids including phosphatidylserine, phosphatidylcholine and phosphatidic acid may be recognized by anti-phospholipid antibodies that are believed to arose early in infection. Here we aimed to investigate the levels of anti-phospholipid antibodies in patients with Lyme borreliosis.

Methods

Participants included in the study:

  • 150 patients with well-defined Lyme borreliosis, of which 30 presented with solitary erythema migrans (EM), 30 with multiple EM (MEM), 30 with Lyme neuroborreliosis (LNB), 30 with Lyme arthritis (LA), 30 with acrodermatitis chronica atrophicans (ACA);
  • 50 patients with nonspecific symptoms and positive borrelial antibodies in serum; and
  • 40 healthy blood donors (control group; samples from healthy blood donors were used to determine the threshold for the assays).

Specimens:

  • 4 serum samples from each individual patient with well-defined Lyme borreliosis (1 before antibiotic treatment, 3 during follow-up up to 1 year);
  • 2 serum samples from patients with nonspecific symptoms and positive borrelial antibodies (1 before antibiotic treatment and one 3 months later);
  • healthy blood donors: 1 serum specimen.

Anti-phospolipid antibodies:

Levels of IgG and IgM isotypes of 4 anti-phospholipid antibodies including anti-cardiolipin (aCL), anti-phosphatidylserine (aPS), anti-phosphatidic acid (aPA) and anti-phosphatidylcholine (aPC) will be analyzed with in-house ELISAs.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Fulfillment of clinical case definition criteria for European Lyme borreliosis (doi: 10.1111/j.1469-0691.2010.03175.x.).

排除标准

  • Autoimmune diseases, acute myocardial infarction, acute deep vein thrombosis, pregnancy, syphilis.

结局指标

主要结局

Anti-phospholipid antibody levels in well-defined clinical manifestations of Lyme disease before antibiotic treatment.

时间窗: Baseline

In all patients with well-defined Lyme borreliosis (EM, multiple EM, LNB, LA, ACA) levels of anti-phospholipid antibodies (AUG/AUM) will be determined before antibiotic treatment.

Levels of anti-phospholipid antibodies in patients with well-defined Lyme borreliosis (EM, multiple EM, LNB, LA, ACA) during the 1-year follow-up after antibiotic treatment.herapy in patients with well-defined Lyme borreliosis

时间窗: Up to one year.

Antiphospholipid antibody levels (AUG/AUM) will be determined in 3 serum samples from each individual patient with well-defined Lyme borreliosis during follow-up up to 1 year.

次要结局

  • Levels of anti-phospholipid antibodies in patients with nonspecific symptoms and positive borrelial antibodies in serum. Levels of anti-phospholipid antibodies in control group (healthy blood donors).(3 months)

研究者

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

Petra Bogovič

MD, PhD

University Medical Centre Ljubljana

研究点 (1)

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