A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Plasma Pharmacokinetic Parameters of Ceftaroline and Avibactam: Area under the plasma concentration versus time curve, Cmax, Tmax, T½, , CL, Vz, and Vss.
研究概览
简要总结
To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC).
详细描述
To evaluate the single-dose pharmacokinetic (PK) profiles of ceftaroline and avibactam following intravenous (IV) administration of ceftaroline fosamil/avibactam ("CXL") in adults with augmented renal clearance (ARC).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults ≥ 18 and ≤ 55 years old
- •Augmented renal clearance, defined as:
- •Estimated CrCl ≥ 115 mL/min (calculated using modified Cockcroft-Gault, before the measured 8-hour urine collection)
- •Measured CrCl ≥ 140 mL/min (from an 8-hour urine collection)
- •Hospitalized and diagnosed with SIRS, defined by at least 2 of the following:
- •Temperature (oral, rectal, tympanic, or core) > 38.5°C or < 35.0°C
- •Heart rate > 90 beats/min
- •Respiratory rate > 20 breaths/min or PaCO2 < 32 mmHg
- •Leukocytosis (> 12,000 white blood cells [WBC]/mm3), leukopenia (< 4000 WBC/mm3), or bandemia (> 10% immature neutrophils [bands] regardless of total peripheral WBC)
- •Requires indwelling urinary bladder catheter per standard of care (through the end of the 8-hour urine collection)
排除标准
- •History of any known hypersensitivity or allergic reaction to cephalosporins or any β-lactam antimicrobial (eg, penicillins)
- •History of chronic kidney disease, hemodialysis, or peritoneal dialysis; or history of acute renal replacement therapy (eg, hemodialysis, hemofiltration) associated with current illness
- •Suspected rhabdomyolysis or creatine kinase > 10,000 U/L
- •Significant anemia defined as hemoglobin < 9 g/dL or hematocrit < 27%
- •Transfusion of packed red blood cells (PRBC) or whole blood within 24 hours of study drug infusion or anticipated need for a transfusion before the last PK blood sample is collected
- •If female, currently pregnant or breastfeeding
研究组 & 干预措施
Ceftaroline fosamil/Avibactam
干预措施: Ceftaroline fosamil/Avibactam (CXL) (Drug)
结局指标
主要结局
Plasma Pharmacokinetic Parameters of Ceftaroline and Avibactam: Area under the plasma concentration versus time curve, Cmax, Tmax, T½, , CL, Vz, and Vss.
时间窗: Up to 3 days
The following PK parameters, if calculable, will be determined for ceftaroline, ceftaroline fosamil, ceftaroline M-1, and avibactam: area under the plasma concentration versus time curve, Cmax, time of maximum plasma drug concentration (Tmax), T½, apparent total body clearance of drug from plasma (CL), apparent volume of distribution during the terminal phase (Vz), and Vss.
次要结局
- Safety and Tolerability of a Single Dose of IV Ceftaroline fosamil and Avibactam.(24-36 hours after last study procedure)