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临床试验/EUCTR2008-005912-41-GB
EUCTR2008-005912-41-GB进行中(未招募)1 期

Temocillin use in Complicated Urinary Tract Infections due to ESBL producing and AmpC hyperproducing Enterobacteriaceae in United Kingdom - TEA trial

Belpharma SA/NV0 个研究点目标入组 50 人开始时间: 2008年10月31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)
发起方
入组人数
50

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

  • patient presenting a complicated urinary tract infection (i.e. acute pyelonephritis, UTI in men, or UTI associated with obstruction, foreign bodies, or urologic abnormalities) due to a confirmed ESBL producing or AmpC hyperproducing Enterobacteriaceae susceptible to temocillin requiring parenteral antimicrobial therapy
  • community or hospital acquired infecting bacteria
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • patients infected with a strain resistant to temocillin (if included at first, then the patient will be kept in the ITT group, therapy will be switched and the patient will be followed for the same time as other enrolled patients).
  • patients having received an active antimicrobial therapy during the 48h before the beginning of temocillin treatment (i.e. having received an antibiotic to which the infecting bacteria is susceptible) except temocillin (i.e. if the patient has been treated empirically with temocillin, they will not be excluded)
  • patients presenting with another site of infection than urinary (except onset of bacteremia from urinary tract origin) due to Gram negative bacteria
  • patients needing concomitant antimicrobial therapy with the exception of benzylpenicillin
  • uncomplicated cystitis
  • complete obstruction of the urinary tract
  • prostatitis
  • perinephretic or intrarenal abscesses
  • renal transplant
  • children (up to 18 years old)
  • pregnancy or lactation
  • chronically dialyzed patients
  • immunocompromising therapy or illness
  • known allergy to penicillin

研究者

发起方
Belpharma SA/NV

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