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临床试验/EUCTR2020-005337-33-NL
EUCTR2020-005337-33-NL进行中(未招募)1 期

EXtended use of FOsfomycin for the treatment of CYstitis in primary care - EXFOCY

niversity Medical Center Utrecht0 个研究点目标入组 741 人开始时间: 2021年4月24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
741

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
Female

入选标准

  • -Adult women (>18 years of age) with a diagnosis of uncomplicated cystitis in primary care
  • -Cystitis diagnosis is according to the flow diagram in the Dutch NHG-guideline. In line with the NHG guideline 2020, recognition of symptoms should always be accompanied with either a positive nitrite test or leucocyte and dipslide test
  • 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 500
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 241

排除标准

  • -Pregnancy
  • -Diabetes Mellitus
  • -Immunocompromised state
  • oUntreated infection with human immunodeficiency virus (hiv)
  • oUse of high-dose systemic corticosteroids
  • oUse of other immunosuppressive medication (specified in protocol)
  • -Presence of an indwelling urinary catheter
  • -History of abnormalities in urinary tract or kidneys
  • -Neurogenic bladder dysfunction
  • -UTI in past 28 days before inclusion
  • -Antibiotic prophylaxis in past 28 days with nitrofurantoin or fosfomycin
  • -Known GFR <30mL/min
  • -Contra-indication for nitrofurantoin or fosfomycin use (e.g. allergic reactions, lung or liver reaction or peripheral neuropathy after previous use in clinical history, acute porphyria, G6PD deficiency)
  • -Current use of an antibiotic for any reason

研究者

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