Imipenem/relebactam pharmacokinetics in critically ill patients supported on extracorporeal membrane oxygenation

J Antimicrob Chemother. 2024 May 2;79(5):1118-1125. doi: 10.1093/jac/dkae079.

Abstract

Background: Extracorporeal membrane oxygenation (ECMO) is a life-saving modality but has the potential to alter the pharmacokinetics (PK) of antimicrobials. Imipenem/cilastatin/relebactam is an antibiotic with utility in treating certain multi-drug resistant Gram-negative infections. Herein, we describe the population pharmacokinetics of imipenem and relebactam in critically ill patients supported on ECMO.

Methods: Patients with infection supported on ECMO received 4-6 doses of imipenem/cilastatin/relebactam per current prescribing information based on estimated creatinine clearance. Blood samples were collected following the final dose of the antibiotic. Concentrations were determined via LC-MS/MS. Population PK models were fit with and without covariates using Pmetrics. Monte Carlo simulations of 1000 patients assessed joint PTA of fAUC0-24/MIC ≥ 8 for relebactam, and ≥40% fT > MIC for imipenem for each approved dosing regimen.

Results: Seven patients supported on ECMO were included in PK analyses. A two-compartment model with creatinine clearance as a covariate on clearance for both imipenem and relebactam fitted the data best. The mean ± standard deviation parameters were: CL0, 15.21 ± 6.52 L/h; Vc, 10.13 ± 2.26 L; K12, 2.45 ± 1.16 h-1 and K21, 1.76 ± 0.49 h-1 for imipenem, and 6.95 ± 1.34 L/h, 9.81 ± 2.69 L, 2.43 ± 1.13 h-1 and 1.52 ± 0.67 h-1 for relebactam. Simulating each approved dose of imipenem/cilastatin/relebactam according to creatinine clearance yielded PTAs of ≥90% up to an MIC of 2 mg/L.

Conclusions: Imipenem/cilastatin/relebactam dosed according to package insert in patients supported on ECMO is predicted to achieve exposures sufficient to treat susceptible Gram-negative isolates, including Pseudomonas aeruginosa.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anti-Bacterial Agents* / administration & dosage
  • Anti-Bacterial Agents* / pharmacokinetics
  • Azabicyclo Compounds* / administration & dosage
  • Azabicyclo Compounds* / pharmacokinetics
  • Azabicyclo Compounds* / therapeutic use
  • Cilastatin, Imipenem Drug Combination / pharmacokinetics
  • Critical Illness*
  • Extracorporeal Membrane Oxygenation*
  • Female
  • Humans
  • Imipenem* / administration & dosage
  • Imipenem* / pharmacokinetics
  • Male
  • Microbial Sensitivity Tests*
  • Middle Aged
  • Monte Carlo Method
  • Tandem Mass Spectrometry

Substances

  • Imipenem
  • relebactam
  • Anti-Bacterial Agents
  • Azabicyclo Compounds
  • Cilastatin, Imipenem Drug Combination

Grants and funding