Open-Label Exploratory, Multiple-Dose Study of Ceftobiprole to Evaluate the Pharmacokinetics and Broncho-Alveolar Penetration in Adults With Ventilator-Associated Pneumonia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 主要终点
- Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine and tissues of the lungs) during dosing and 24 hours after last dose infused
研究概览
简要总结
The purpose of this research study is to measure the levels of ceftobiprole in the blood, urine and tissues of the lungs during and after administration of four doses of ceftobiprole. Safety of the drug will also be evaluated.
详细描述
Patients will receive a intravenous dose of ceftobiprole infused over 4 hours. Multiple blood samples will be obtained to determine the concentration of Ceftobiprole in the blood. Bronchoalveolar lavage (BAL) samples will be collected to determine the concentration of ceftobiprole in the BAL fluid. The penetration of the drug into the lung will be calculated. Four 1000mg administered every 8 hours
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 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
- •VAP - 48 hours after onset of mechanical ventilation
- •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
- •Renal impairment (CrCl < 80 mL/min)
- •Known drug allergy (including penicillin, cephalosporin, carbapenems, or other beta-lactams)
- •History of seizures
- •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
Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days
干预措施: Ceftobiprole (Drug)
结局指标
主要结局
Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine and tissues of the lungs) during dosing and 24 hours after last dose infused
时间窗: 2 days
次要结局
- Safety will be evaluated throughout the study.(Study Duration)