跳至主要内容
临床试验/EUCTR2016-002052-24-IT
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)

研究者

发起方
OSPEDALE SAN RAFFAELE

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