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临床试验/EUCTR2015-001481-25-NO
EUCTR2015-001481-25-NO进行中(未招募)1 期

yme borreliosis; a scientific approach to reduce diagnostic and therapeutic uncertainties (BorrSci)WP2; SIX VERSUS TWO WEEKS TREATMENT WITH DOXYCYCLINE IN LYME NEUROBORRELIOSIS; A MULTICENTER, NON-INFERIORITY, PENTA-BLIND, RANDOMIZED TRIAL - BorrSciWP2

Sørlandet Sykehus HF0 个研究点目标入组 250 人开始时间: 2015年8月27日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
250

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Neurological symptoms suggestive of LNB without other obvious reasons and one or both of
  • a .Cerebrospinal fluid pleocytosis (>5 leukocytes/mm3)
  • b. Intrathecal Bb antibody production
  • 2.Signed informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 200
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 50

排除标准

  • -?Age less than 18 years
  • -?Pregnancy, breast-feeding
  • -?Adverse reaction to tetracyclines
  • -?Treatment with cephalosporin, penicillin, or tetracycline the last 14 days
  • -?Serious liver or kidney disease that contraindicates use of doxycyline
  • -?Lactose intolerance
  • - Need to use medications contraindicated according to SmPC of the IMP

研究者

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