Effect of Continuous Renal Replacement Therapy and Residual Renal Clearance on Cefiderocol Pharmacokinetics in Critically Ill Adult Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Cefiderocol concentration
研究概览
简要总结
Continuous renal replacement therapies (CRRT) such as continuous venovenous hemofiltration are used to provide renal support for critically ill patients with acute kidney injury (AKI), particularly patients who are hemodynamically unstable. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how CRRT affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, Cefiderocol, in critically ill patient receiving CRRT.
详细描述
This is a prospective, multi-center, open-label, Phase 1b, pharmacokinetic study of Cefiderocol in 16 critically ill patients receiving CRRT support. Informed consent will be collected from all study participants, legal authorized representative, or their next of kin in order to participate. This is not a treatment study; all participants will receive standard of care antibiotics which may include cefiderocol as necessary to treat any current infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older;
- •Receiving CRRT including CVVH, CVVHD, and CVVHDF support.
排除标准
- •Females who are pregnant or breast-feeding;
- •History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication);
- •A hemoglobin less than 8 gm/dl at baseline;
- •Acute liver injury, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the upper limit of normal, or AST or ALT > 3 times the upper limit of normal with an associated total bilirubin > 2 times upper limit of normal;
- •Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator);
- •Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data.
研究组 & 干预措施
Cefiderocol
Participants will receive four to six doses of Cefiderocol as per current prescribing information based on effluent rate
干预措施: Cefiderocol (Drug)
结局指标
主要结局
Cefiderocol concentration
时间窗: 8 to 12 hours
The total and free plasma concentration of cefiderocol over time
Cefiderocol clearance
时间窗: 8 to 12 hours
The Clearance in liters/hour of Cefiderocol from the plasma
Cefiderocol maximum concentration
时间窗: 8 to 12 hours
The maximum concentration of Cefiderocol from the plasma
次要结局
未报告次要终点
研究者
Tomefa Asempa
Associate Director, Clinical and Translational Infectious Diseases Research
Hartford Hospital