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临床试验/ACTRN12614001211651
ACTRN12614001211651招募中4 期

Pilot Randomised Controlled Trial of Meropenem versus Piperacillin-Tazobactam for Definitive Treatment of Bloodstream Infections caused by AmpC beta-lactamase producing Enterobacter spp., Citrobacter freundii, Morganella morganii, Providencia spp. or Serratia spp.

The University of Queensland Centre for Clinical Research0 个研究点目标入组 100 人开始时间: 2014年11月17日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • a.Bloodstream infection with Enterobacter spp., Serratia marcescens, Providencia spp., Morganella morganii or Citrobacter freundii (i.e. likely AmpC-producer), and susceptibility to 3rd generation cephalosporins (i.e. ceftriaxone, cefotaxime or ceftazidime), meropenem and piperacillin-tazobactam from at least one blood culture draw. This will be determined in accordance with laboratory methods and susceptibility breakpoints defined by protocols used in the recruiting site laboratories.
  • b.No more than 72 hours has elapsed since the first positive blood culture collection.
  • c.Patient is aged 18 years and over (>=21y in Singapore).

排除标准

  • a. Patient not expected to survive more than 4 days
  • b. Patient allergic to a penicillin or a carbapenem
  • c. Patient with significant polymicrobial bacteraemia (that is, a Gram positive skin contaminant in one set of blood cultures is not regarded as significant polymicrobial bacteraemia).
  • d. Treatment is not with the intent to cure the infection (that is, palliative care is an exclusion).
  • e. Pregnancy or breast-feeding.
  • f. Use of concomitant antimicrobials in the first 4 days after enrolment with known activity against Gram-negative bacilli (except trimethoprim/sulphamethoxazole may be continued as Pneumocystis prophylaxis).
  • g. Likely source to be from (proven or suspected at the time of randomisation) the central nervous system, e.g. brain abscess, post-surgical meningitis, shunt infection (due to concerns over CNS penetration of piperacillin/tazobactam)

研究者

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