NCT03873974已完成不适用
Multicentre Clinical Trial to Assess the Performance of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis From Blood Samples of Subjects Who Are Either Pharmacotherapy-naive or Treatment-experienced and Their Physician Indicates Drug Therapy for Lyme Borreliosis
Lyme Diagnostics Ltd.8 个研究点 分布在 6 个国家目标入组 400 人开始时间: 2019年7月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 8
- 主要终点
- Primary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System)
研究概览
简要总结
The clinical data from the clinical trial will be used to assess the performance, sensitivity and specificity of the experimental DualDur In Vitro Diagnostic System.
详细描述
The clinical data from the clinical trial will be used to assess the performance, sensitivity and specificity of the experimental DualDur In Vitro Diagnostic System.
- The sensitivity of the DualDur in Vitro Diagnostic System will be examined in subjects whose physician indicates drug therapy for Lyme borreliosis (positive arm).
- The specificity of the DualDur in Vitro Diagnostic System will be examined in healthy volunteers declared Lyme borreliosis negative by their physician and all the standard laboratory tests prove that they are free of Lyme borreliosis (negative arm).
The diagnostic system developed by Lyme Diagnostics Ltd. is planned for application in the diagnosis during the entire life cycle of Lyme borreliosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Man or female subjects over 18 years of age
- •Treatment-naive or treatment-experienced subjects with Lyme borreliosis, whose physician indicates drug therapy for Lyme borreliosis.
- •Subjects capable of reading, understanding, and observing the requirements of the clinical trial, who sign the Patient Information Leaflet and Informed Consent Form approved by the Competent Authority and the Ethics Committee.
排除标准
- •Man or female subjects over 80 years of age
- •Pregnancy, breastfeeding
- •History of any complication related to previous blood sampling
- •Coagulation and/or bleeding disorders
- •Anticoagulant therapy
- •Acute, life-threatening condition
- •Participation in another clinical trial
- •The patient is under antibiotic therapy, or received such treatment in the preceding 3 months
- •The patient is currently taking or has taken in the preceding 6 months dietary supplements of herbal origin, or medicinal herbs as first-line or add-on treatments for Lyme borreliosis
- •In the event the patient has previously been treated for Lyme borreliosis, then this treatment took place less than 6 months before blood sampling.
- •In the preceding 6 months, the patient used an electronic device operating along the principle of electromagnetic (i.e. electric or magnetic) fields - such as bioresonance, pulsed magnetic field, etc. - as add-on treatment for Lyme borreliosis.
- •II. Negative trial arm
- •Inclusion Criteria:
- •Man or female subjects over 18 years of age
- •Asymptomatic healthy volunteer subjects without acute or chronic symptoms of Lyme borreliosis, who are free of Lyme borreliosis by the indication of all standard laboratory tests, and who are willing to take part in a comprehensive medical examination and related blood sampling.
- •Subjects capable of reading, understanding, and observing the requirements of the trial, who sign the Patient Information Leaflet and Informed Consent Form approved by the Competent Authority and the Ethics Committee.
- •Exclusion Criteria:
- •Man or female subjects over 80 years of age
- •Pregnancy, breastfeeding
- •History of any complication related to previous blood sampling
- •Coagulation and/or bleeding disorders
- •Anticoagulant therapy
- •Participation in another clinical trial
- •Lyme borreliosis diagnosed previously, at any time during the life of the subject
- •The subject has received any treatment for Lyme borreliosis (medicinal products, dietary supplements, medicinal plants, electronic devices, etc.) during his/her life
- •The patient is under antibiotic therapy, or received such treatment in the preceding 3 months
- •The occupation of the subject is either a forester or a hunter
结局指标
主要结局
Primary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System)
时间窗: Laboratory samples evaluated within 72-144 hours of sampling.
The sensitivity of the experimental DualDur in Vitro Diagnostic System in the positive arm, based on medical diagnosis
Primary endpoint, 2 (specificity of the experimental DualDur In Vitro Diagnostic System)
时间窗: Laboratory samples evaluated within 72-144 hours of sampling.
The specificity of the experimental DualDur In Vitro Diagnostic System in the negative arm, based on medical diagnosis and all the standard laboratory test results
次要结局
- Secondary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System)(Laboratory samples evaluated within 72-144 hours of sampling.)
- Secondary endpoint, 2 (Pairwise comparison of the sensitivity of the experimental DualDur in Vitro Diagnostic System and of the direct/indirect diagnostic methods)(Laboratory samples evaluated within 72-144 hours of sampling.)
研究者
研究点 (8)
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