Ex Vivo Sequestration and Pharmacokinetics of Cefiderocol in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Cefiderocol Clearance
研究概览
简要总结
Extracorporeal membrane oxygenation (ECMO) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. 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 ECMO circuits 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 ECMO.
详细描述
This is a prospective, open-label, Phase 1b, pharmacokinetic study of Cefiderocol in 8 critically ill patients receiving ECMO support at Hartford Hospital. 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 other antibiotics 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
- Other
- 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 or older
- •On support with veno-venous- or veno-arterial-ECMO
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)
- •Receiving Cefiderocol to treat documented or suspected infection within 72 hours of screening, or expected to receive Cefiderocol during the study intervention phase
- •Severe renal dysfunction defined as a CrCL < 15 mL/min (as calculated by the Cockcroft Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis
- •A hemoglobin less than 7.2 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 calculated creatinine clearance.
干预措施: Cefiderocol (Drug)
结局指标
主要结局
Cefiderocol Clearance
时间窗: 8 hours
The Clearance in liters/hour of Cefiderocol from the plasma of critically ill patients receiving ECMO.
次要结局
- Cefiderocol Area Under the Curve (AUC)(8 hours)
研究者
Joseph L. Kuti, PharmD
Director, Center for Anti-Infective Research and Development
Hartford Hospital