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临床试验/NL-OMON25501
NL-OMON25501暂停不适用

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

MC Utrecht0 个研究点目标入组 777 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
777

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

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
  • -Urine collection is performed according to the Dutch NHG-guideline

排除标准

  • -Presence of signs of tissue invasion according to NHG guideline: fever, malaise, chills, flank or perineal pain, signs of sepsis or delirium
  • -Pregnancy or nursing*
  • -Diabetes Mellitus
  • -Immunocompromised state:
  • oUntreated infection with human immunodeficiency virus (hiv)
  • oUse of high-dose systemic corticosteroids
  • oUse of other immunosuppressive medication
  • -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 (current or in past 28 days)with nitrofurantoin or fosfomycin or trimethoprim.
  • -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
  • -Previous inclusion in EXFOCY
  • -Presence of urine cultures showing resistance for nitrofurantoin or fosfomycin in the last 12 months

研究者

发起方
MC Utrecht

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