Anti-phospholipid Antibodies in Adult Patients With Different Clinical Manifestations of Lyme Borreliosis
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
- 是
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
Petra Bogovič
MD, PhD
University Medical Centre Ljubljana
