Lyme Borreliosis and Early Cutaneous Diagnostic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 9
- 主要终点
- Compare the sensitivity (percentage of positive tests) of the SRM / MS-MS to techniques of PCR and culture Borrelia
研究概览
简要总结
Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with the early skin manifestation (erythema migrans).
This new proteomic method will be compared to the two existing method: culture of Borrelia and PCR detection of Borrelia (DNA detection of the bacteria).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Erythema migrant as criteria EUCALB or atypical form associated to tick's sting
- •Patient having signed a consent
- •Patient affiliated to a social security scheme
排除标准
- •Prior treatment with antibiotics
- •Erythema migrans on the face
- •Bleeding disorders
- •Anticoagulant treatment
- •Inability to give clear information (subject in an emergency situation, understanding of the topic difficulty, ...)
研究组 & 干预措施
SRM / MS-MS
干预措施: Skin biopsies (Procedure)
结局指标
主要结局
Compare the sensitivity (percentage of positive tests) of the SRM / MS-MS to techniques of PCR and culture Borrelia
时间窗: One year study
percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture)
Compare the Sensitivity (Percentage of Positive Tests) of the SRM / MS-MS to Techniques of PCR and Culture Borrelia
时间窗: At inclusion (Day 0), immediately after skin biopsy sampling, with laboratory analysis performed subsequently (culture up to 8 weeks for Borrelia growth, PCR and targeted proteomics after sample processing).
Percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture)
次要结局
未报告次要终点