Preliminary Research On Two-step Dosing Of Imipenem/Cilastatin
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
Explore Imipenem/Cilastatin two-step dosing compared to 2 hours infusion in patients with severe whether can obtain better results of the pharmacokinetic/pharmacodynamic, for clinical rational use of antimicrobial agents, and provide theoretical support for optimizing dosage regimen.
详细描述
Compared with Imipenem/Cilastatin 2 hours continuous dosing method and two-step dosing method (0.5 hours before enter half dose, after 1.5 hours, the other half of the input dose) of blood drug concentration in the body than the minimal inhibitory concentrations (MIC) pathogens percent of dosing interval duration (100% fT > MIC), blood drug concentration in the body more than 4 times the minimal inhibitory concentrations (MIC) pathogens percent of dosing interval duration (100% fT > 4 MIC), blood drug concentration peak and the ratio of the minimal inhibitory concentrations (MIC) pathogens (Cmax/MIC), blood drug concentration (Tmax) used in the peak time, used to guide clinical patients with severe infection of Imipenem/Cilastatin usage.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sepsis or severe sepsis or severe infections in the previous 48 hours
- •treatment with imipenem/cilastatin (recommended by hospital microbiologists)
- •expected duration of hospital stays in the ICU ≥ 72 h from recruitment
- •recruited patients agreed to participate in this trial, and had set up a signed informed consent
排除标准
- •with an allergy to carbapenems or with an adverse drug reaction to imipenem
- •acute or chronic renal failure assessed by serum creatinine concentrations > 280 μmol/L (or creatinine clearance <20mL/min) or those requiring continuous renal replacement therapy
- •drug or alcohol abuse
- •Pregnant and lactant women
- •patients near to death
研究组 & 干预措施
Group I
Group I received intravenous imipenem/cilastatin 1 g every 8 h (q8h) or 0.5g every 6 h (q6h) with optimized two-step infusion therapy (OTIT; rapid first-step infusion in 30 min and slow second-step infusion above 1.5 hours) "Group I" is more informative than "Group II" from PK parameters(%T>MIC,AUC/MIC).
干预措施: Imipenem (Drug)
Group II
group II received intravenous imipenem/cilastatin 1g q8h or 0.5g q6h with extended infusion therapy (2-hours continuous infusion in a constant speed).
"Group I" is more informative than "Group II" from PK parameters(%T>MIC,AUC/MIC).
干预措施: Imipenem (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: up to 9 months
次要结局
- Plasma Concentration(up to 9 months)
研究者
Jianfeng Xie
Deputy director of the physician
Southeast University, China