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      Application of Monte Carlo simulation to optimise the dosage regimen of meropenem in patients with augmented renal clearance for Pseudomonas aeruginosa infection

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          Abstract

          Objective

          To optimise the dosing regimen of meropenem for treating Pseudomonas aeruginosa (PA) infections in critically ill patients with augmented renal clearance (ARC) using pharmacokinetic/pharmacodynamic (PK/PD) principles and Monte Carlo simulation (MCS).

          Methods

          This research involves an MCS based on PK data from patients with ARC and a minimum inhibitory concentration (MIC) distribution of PA. This study simplifies the methods section, focusing on the critical aspects of simulation and target values for effective treatment.

          Results

          The study highlights key findings and emphasises that tailored dosing based on bacterial MIC values is essential for patients with ARC. It also notes that empirical treatment in patients with ARC should consider the MIC distribution, with 2 g every (q) 6 h administered to achieve the PK/PD target, while 3 g q 6 h is effective in inhibiting resistance.

          Conclusion

          Tailored dosing based on bacterial MIC values is crucial for patients with ARC. Prolonged infusion time alone does not enhance efficacy. Empirical treatment in patients with ARC should consider MIC distribution; a dosage of 2 g q 6 h achieves the PK/PD target, while 3 g q 6 h (≥12 g daily) inhibits resistance.

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          Most cited references37

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          Clinical pharmacodynamics of meropenem in patients with lower respiratory tract infections.

          Chonghua Li, Xiaoli Du, Joseph L. Kuti … (2007)
          Studies of beta-lactam pharmacodynamics in infected patients are sparse. In this study, classification and regression tree (CART) and logistic regression analyses were used to identify which pharmacodynamic indices and magnitudes were significant predictors of meropenem efficacy for 101 adult patients with lower respiratory tract infections (LRTI). Using demographic data, a validated population pharmacokinetic model was employed to predict pharmacokinetic parameters and free serum concentrations in the studied patients. Pharmacodynamic indices [percentage of the dosing interval that free drug concentrations remain above the MIC (% fT > MIC), f(maximum concentration of drug in serum) (fC(max))/MIC, fC(min)/MIC, and f(area under the concentration-time curve) (fAUC)/MIC] were calculated based on the baseline pathogen with the highest drug MIC for each patient. The median (range) of percent fT > MIC, fC(max)/MIC, fC(min)/MIC, and fAUC/MIC were 100% (0 to 100%), 728.8 (0.8 to 15,777), 19.9 (0.01 to 278), and 3,605.4 (2.7 to 60,865.9), respectively. CART identified the following breakpoints as significant predictors for microbiological response: >54% fT > MIC, a fC(max)/MIC > 383, and a fC(min)/MIC > 5; fC(min)/MIC > 5 was the only significant predictor of clinical response. Due to 100% fT > MIC achieved in the majority of LRTI patients, fC(min)/MIC was the statistically significant parameter associated with meropenem clinical and microbiological response in the adults with LRTI. The findings for LRTI patients can be applied to optimize meropenem dose regimens to achieve clinical success and microbiological eradication in clinical practice.
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            Prolonged versus short-term intravenous infusion of antipseudomonal β-lactams for patients with sepsis: a systematic review and meta-analysis of randomised trials

            Konstantinos Z. Vardakas, Georgios Voulgaris, Athanasios Maliaros … (2018)
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              Meropenem and piperacillin/tazobactam prescribing in critically ill patients: does augmented renal clearance affect pharmacokinetic/pharmacodynamic target attainment when extended infusions are used?

              Mieke Carlier, Sofie Carrette, Jason A Roberts … (2013)
              Background Correct antibiotic dosing remains a challenge for the clinician. The aim of this study was to assess the influence of augmented renal clearance on pharmacokinetic/pharmacodynamic target attainment in critically ill patients receiving meropenem or piperacillin/tazobactam, administered as an extended infusion. Methods This was a prospective, observational, pharmacokinetic study executed at the medical and surgical intensive care unit at a large academic medical center. Elegible patients were adult patients without renal dysfunction receiving meropenem or piperacillin/tazobactam as an extended infusion. Serial blood samples were collected to describe the antibiotic pharmacokinetics. Urine samples were taken from a 24-hour collection to measure creatinine clearance. Relevant data were drawn from the electronic patient file and the intensive care information system. Results We obtained data from 61 patients and observed extensive pharmacokinetic variability. Forty-eight percent of the patients did not achieve the desired pharmacokinetic/pharmacodynamic target (100% fT>MIC), of which almost 80% had a measured creatinine clearance >130 mL/min. Multivariate logistic regression demonstrated that high creatinine clearance was an independent predictor of not achieving the pharmacokinetic/pharmacodynamic target. Seven out of nineteen patients (37%) displaying a creatinine clearance >130 mL/min did not achieve the minimum pharmacokinetic/pharmacodynamic target of 50% fT>MIC. Conclusions In this large patient cohort, we observed significant variability in pharmacokinetic/pharmacodynamic target attainment in critically ill patients. A large proportion of the patients without renal dysfunction, most of whom displayed a creatinine clearance >130 mL/min, did not achieve the desired pharmacokinetic/pharmacodynamic target, even with the use of alternative administration methods. Consequently, these patients may be at risk for treatment failure without dose up-titration.
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                Author and article information

                Contributors
                Jin-Feng Li
                Journal
                Journal ID (nlm-ta): Heliyon
                Journal ID (iso-abbrev): Heliyon
                Title: Heliyon
                Publisher: Elsevier
                ISSN (Electronic): 2405-8440
                Publication date PMC-release: 07 June 2024
                Publication date Collection: 30 June 2024
                Publication date (Electronic): 07 June 2024
                Volume: 10
                Issue: 12
                Electronic Location Identifier: e32600
                Affiliations
                [a ]Department of Pharmacy, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, 264200, China
                [b ]Department of Clinical Laboratory, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, 264200, China
                [c ]Department of Central Laboratory, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, 264200, China
                Author notes
                [* ]Corresponding author. Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, No. 70 of Heping Street, Huancui District, Weihai, 264200, China. lijinfeng60@ 123456126.com
                Article
                Publisher Item ID: S2405-8440(24)08631-6 Publisher ID: e32600
                DOI: 10.1016/j.heliyon.2024.e32600
                PMC ID: 11225735
                SO-VID: faed0475-34ac-4ff5-a55b-14bad361883f
                Copyright © © 2024 The Authors. Published by Elsevier Ltd.
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 7 December 2023
                Date revision received : 5 June 2024
                Date accepted : 5 June 2024
                Categories
                Subject: Research Article

                Keywords: monte carlo simulation,meropenem,pseudomonas aeruginosa,augmented renal clearance,pharmacokinetic/pharmacodynamic
                Data availability:
                Keywords: monte carlo simulation, meropenem, pseudomonas aeruginosa, augmented renal clearance, pharmacokinetic/pharmacodynamic

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