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.
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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