EUCTR2015-004219-19-ES进行中（未招募）1 期
Randomized, multicenter, open, phase III, controlled clinical trial, to demonstrate the non-inferiority of reduced antibiotic treatment directed against the treatment of a broad spectrum betalactam antipseudomonal in treating patients with bacteremia spectrum Enterobacteriaceae
FISEVI0 个研究点目标入组 344 人开始时间: 2016年2月3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
- 344
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
- •1) ?18 years old hospitalized patients with bacteremia from any source with isolation of an enterobacteria in blood cultures.
- •2) Active empiric treatment with antipseudomonic betalactamic at 48 hours from the symptoms of sepsis and the blood culture.
- •3) Microorganism susceptible at least one treatment from the experimental arm.
- •4) Patients with intravenous treatment at least 5 days.
- •5) Patients to sign the 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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •1 )Palliative care or life expectance < 90 days.
- •2) Pregnancy or lactation period.
- •3) To isolate the Extended-spectrum ?-lactamases producing Enterobactericiae
- •4) Late randomization >48 hours after the enterobactericiae blood culture´s identification
- •5) Severe neutropenic (< 500 céls/mm3) at the randomization.
- •6) Treatment of infection > 28 days (endocarditis and osteomyelitis) or meningitis.
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