EUCTR2016-002195-27-EE进行中（未招募）1 期
Pharmacokinetics and tissue penetration of amoxicillin/clavulanic acid in patients with sepsis and septic shock
niversity of Tartu0 个研究点开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Study inclusion criteria:
- •1)Age 18 years
- •2)Sepsis or septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)1:
- •1.Sepsis - life-threatening organ dysfunction caused by a dysregulated host response to infection; that is suspected or documented infection and an acute increase of =2 SOFA points (a proxy for organ dysfunction)
- •2.Septic shock - sepsis with persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) =65mmHg and having a serum lactate level >2 mmol/L despite adequate volume resuscitation.
- •3)Antibacterial treatment with amoxicillin/clavulanic acid in the dose of 1.2g every 8 hours prescribed by the treating physician
- •4)Informed consent given by the patient or next of kin
- •Arterial catheter in place on clinical indication
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •Study exclusion criteria:
- •1)Necessity of renal replacemen??t therapy
- •2)History of allergic reaction to amoxicillin or other penicillins
- •3)Absence of an arterial catheter
- •Absence of informed consent
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