Open-Label, Parallel Group, Multiple-dose Study of Ceftobiprole to Evaluate the Plasma Pharmacokinetics in Adults in Intensive Care Units
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine) during dosing and 24 hours after last dose
研究概览
简要总结
The purpose of this research study is to measure the levels of ceftobiprole in the blood and urine during and after administration of four doses of ceftobiprole. Safety of the drug will also be evaluated.
详细描述
Patients will receive an intravenous dose of ceftobiprole infused over 4 hours. Multiple blood samples will be obtained to determine the concentration of ceftobiprole in the plasma. Pharmacokinetic parameters such as clearance and volume of distribution will be calculated. 1000mg every 8hours or every 12 hours
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Informed Consent
- •Between 18 and 75 years of age inclusive
- •BMI 18 - 35 inclusive
- •Albumin < 3.3 g/dL or clinical evidence of edema
- •Negative Pregnancy test
- •Expected survival of at least 7 days
排除标准
- •Known drug allergy (including penicillin, cephalosporin, carbapenems, or other beta-lactams)
- •Renal impairment (CrCl < 50 mL/min) or dialysis
- •History of seizures
- •ALT or AST > 5 times upper normal limit
- •Sustained shock, unresponsive to sympathomimetics
- •Conditions that may have jeopardized adherence to the protocol (NYHA Class 4 cardiac disease, >15% total body burn or significant third degree burn)
研究组 & 干预措施
Ceftobiprole q12h
Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2
干预措施: ceftobiprole q12h (Drug)
Ceftobiprole q8h
Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2
干预措施: ceftobiprole q8h (Drug)
结局指标
主要结局
Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine) during dosing and 24 hours after last dose
时间窗: 3 days
次要结局
- Safety will be evaluated throughout the study.(7 days)