Pharmacodynamics of Ertapenem in Patients With Urosepsis
试验速览
- 阶段
- 4 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Concentration of ertapenem in plasma
研究概览
简要总结
Ertapenem, a broad-spectrum carbapenem antibiotic, has shown promising in vitro activity agenst ESBL-producing Enterobacteriacae. This agent was licensed in United State of America and Europe for several clinical use in complicated intraabdominal infections, complicated skin and skin-structure infections, acute pelvic infections, complicated urinary tract infections and community-acquired pneumonia. In common with other beta-lactams, ertapenem exhibits primarily time-dependent activity, and the percentage of the exposure time during which the free drug concentration remain above the MIC (%T>MIC) is the pharmacokinetic/pharmacodynamics (PK/PD) index that best correlates with efficacy. Pathophysiological changes in critically ill patients with severe infections resulting in altered PK patterns that may affect therapeutic plasma concentrations and achievement of PD have been found with several antimicrobial agents. The aim of the study was to determine the PK of ertapenem in patients with urosepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •>18 years of age
- •Diagnosis of urosepsis
排除标准
- •They were pregnant
- •Circulatory shock (defined as a systolic blood pressure of < 90 mmHg and pour tissue perfusion)
- •Documented hypersensitivity to carbapenems
- •Estimated creatinine clearance (CLcr) (determined by the Crockcroft-Goult method) of < 30 mL/min
研究组 & 干预措施
Ertapenem in urosepsis
Ertapenem PK studies were carried out on the 3rd dose of ertapenem administration. Blood samples (3 mL) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 h after the start of ertapenem administration. All blood samples were added to a heparinized tube and centrifuged at 1,000 g for 10 min at 4°C within 5 min.
干预措施: Ertapenem Injection (Drug)
结局指标
主要结局
Concentration of ertapenem in plasma
时间窗: 48 hours after the ertapenem dose
次要结局
未报告次要终点
研究者
Sutep Jaruratanasirikul
Principle Investigator
Prince of Songkla University