drugset / Trial / NCT04147221

Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance

NCT04147221

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

EvaluationDrugModalityDoseRoute
Subject IMIPENEM ANHYDROUS Small molecule 500 mg Intravenous
Subject Relebactam Small molecule 250 mg Intravenous