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临床试验/NCT03956212
NCT03956212已完成不适用

Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With Erythema Migrans

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年6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
150
试验地点
1
主要终点
inflammatory proteins in erythema migrans patients

研究概览

简要总结

The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better insight into pathogenesis of early Lyme borreliosis and to define new immune modulators that could serve as biomarkers of disease activity.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • erythema migrans in patients > 18 years

排除标准

  • pregnancy or immunocompromising conditions
  • taking antibiotic with antiborrelial activity within 10 days

研究组 & 干预措施

erythema migrans patients treated with doxycycline

Experimental

adult patients with erythema migrans will be treated with oral doxycycline

干预措施: Doxycycline 7 days (Drug)

erythema migrans patients treated with doxycycline

Experimental

adult patients with erythema migrans will be treated with oral doxycycline

干预措施: Doxycycline 14 days (Drug)

结局指标

主要结局

inflammatory proteins in erythema migrans patients

时间窗: up to 12 months follow-up

The inflammatory immune profiles will be assessed using Luminex to measure the expression of cytokines and chemokines representative of innate and adaptive TH1, TH2, TH17, and B cell responses in serum and if available, skin, of patients during active infection and after treatment.

次要结局

  • gene polymorphisms in erythema migrans patients(at enrollment)

研究者

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

Daša Stupica

Principal Investigator

University Medical Centre Ljubljana

研究点 (1)

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