drugset / Trial / NCT04147221
Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance
NaSingle-groupOpen-labelOther
Summary
Critically ill patients with sepsis undergo several physiological alterations that can alter the distribution, metabolism, and elimination of drugs. Some patients with sepsis may realize enhanced cardiac output leading to increases in glomerular filtration that result in increasing drug clearance. This clinical state is referred as Augmented Renal Clearance (ARC). Importantly, many beta-lactam antibiotics can be adversely affected by ARC, and some of these agents required increasing dosage to compensate for enhanced clearance. Imipenem-relebactam is a new broad spectrum antibiotic. This study is designed to assess the pharmacokinetics of both components, imipenem and relebactam, in critically ill patients with ARC.
Timeline
- Start
- 2020-02-10
- Primary completion
- 2021-09-10
- Completion
- 2021-09-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IMIPENEM ANHYDROUS | Small molecule | 500 mg | Intravenous |
| Subject | Relebactam | Small molecule | 250 mg | Intravenous |