EUCTR2013-002922-21-ES进行中（未招募）1 期
Randomized, phase III, multicentre, open-labelled clinical trial, to evaluate the efficacy of fosfomycin vs meropenem in the treatment of bacteremic urinary tract infection caused by Escherichia coli producing extended-spectrum beta-lactamases (ESBL).
FISEVI0 个研究点目标入组 198 人开始时间: 2014年2月18日最近更新:
适应症
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
- 198
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
入选标准
- •* Adult (over 18) hospitalized patients diagnosed with bacteremia due to urinary tract infection by E. coli extended spectrum beta-lactamase (ESBL).
- •*Isolation of this microorganism in blood culture with clinical sepsis without other obvious or the most likely origin of the urinary bacteremia.
- •*Required intravenous treatment during 5 days at least.
- •*Women of childbearing potential must have a negative pregnancy test.
- •*Signed informed consent form.
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •*Polymicrobial bacteremia.
- •*Undrained renal abscess or not resolved urinary tract obstruction.
- •*Prostatitis.
- •*Haematogenous or contiguous urinary infection
- •*Concomitant infections
- •*Polycystic kidney disease.
- •*Renal trasplantation.
- •*Allergy or hypersensitivity to fosfomycin or meropenem.
- •*Terminal condition, or life expectancy less than 90 days, or palliative treatment of the underlying disease.
- •*Delayed inclusion > 12 hours since the identification of E. coli ESBL in blood culture.
- •*Patients participating in other clinical trial.
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