Efficacy and Pharmacokinetics of Meropenem in Different Administration for Patients With Severe Sepsis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- T>MIC
研究概览
简要总结
The experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data
详细描述
This study is a prospective, randomized controlled trial, which the subjects were severe sepstic patients for selecting Meropenem as antimicrobial drugs. The experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data, eventually demonstrate the effecacy and safety of Meropenem in patients with severe infection and optimize the best clinical practice for antimicrobial agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients, whose informed consent has been obtained;
- •Clinical diagnosis of Sepsis
排除标准
- •Pregnancy or lactation;
- •Treated with other carbapenems;
- •Cannot be evaluated for efficacy and safety result from lack of clinical and laboratory parameter for Infection assessment;
- •Allergy to meropenem or other β-lactams, or the history of allergy;
- •Resistant to meropenem according to the antimicrobial susceptibility test;
- •Epilepsy or history of epilepsy;
- •History of seizures;
- •Combined medicine with sodium valproate;
- •Combined medicine with anti-MRSA, anti-fungal drugs;
- •with severe liver or renal dysfunction;
- •Terminal cancer;
- •Septic shock;
- •APACH II ≥20;
- •Inappropriate to participate in the trial evaluated by investigator.
研究组 & 干预措施
Experimental group
meropenem injection, 1.0g, q8h,intravenous infusion ,0.5g/0.5h+0.5g/4h
干预措施: Meropenem Injection (Drug)
Control group
meropenem injection, 1.0g, q8h,continuous intravenous infusion duration ,1h
干预措施: Meropenem Injection (Drug)
结局指标
主要结局
T>MIC
时间窗: Day 1
Time above MIC% per administration interval
次要结局
- SOFA(Day 0,Day 4,Day 8)
- Mortality(Day 28)
- highest temperature(Day 0,Day 4,Day 8)
- APACHE II score(Day 0,Day 4,Day 8)