EUCTR2016-002052-24-IT进行中(未招募)1 期
Continuous infusion versus intermittent administration of meropenem in critically ill patients. A multicenter randomized double blind trial. - Bolus versus continuous infusion of meropenem.
OSPEDALE SAN RAFFAELE0 个研究点目标入组 600 人开始时间: 2020年11月4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
- 600
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. Are at least 18 years old
- •2. Need a new antibiotic treatment, by clinical judgment, with meropenem
- •3. Are admitted to ICU
- •4. Have Sepsis or septic shock
- •5. Are able to express informed consent or by him/her next of kin or as requested by Ethical Committee.
- •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 300
排除标准
- •.1. Are able to express informed consent and denying it
- •2. Are already receiving study drug or other carbapenem both as a bolus or continuous infusion
- •3. Have a known allergy or intolerance to study drug
- •4. Have a little chance of survival, as defined by a SAPS II score more than 65 point
- •5. Have concomitant acquired immunodeficiency syndrome (stage 3 according to CDC)
- •6. Have received immunosuppressant or long-term corticosteroid therapy (more than 0.5 mg/kg/day for over 30 days)
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