Empirical Meropenem Dosing in Critically Ill Patients: Early Assessment of Plasma Exposure and Minimum Inhibitory Concentration Targets

The goal of this prospective cohort study is to characterize meropenem exposure in critically ill adult patients receiving empiric antibiotic treatment in the intensive care unit (ICU). Empiric treatment refers to the administration of antibiotics before the causative microorganism and its antimicrobial susceptibility profile are known. In clinical practice, meropenem is commonly administered using different dosing strategies, including 1 g or 2 g doses given as either a 30-minute or a 3-hour infusion. The minimum inhibitory concentration (MIC) is the lowest concentration of an antibiotic required to inhibit bacterial growth and is used as a reference value to evaluate antibiotic exposure. The main questions it aims to answer are: Do meropenem plasma concentrations differ between patients receiving 1 g and those receiving 2 g, administered as either a 30-minute or a 3-hour infusion during the first 48 hours of empirical treatment in critically ill patients? Does the duration of time above the theoretical MIC of 2 mg/L differ between patients receiving meropenem 1 g and those receiving 2 g, administered as either a 30-minute or a 3-hour infusion during the first 48 hours of empirical treatment in critically ill patients? Researchers will compare different meropenem dosing regimens (1 g versus 2 g administered as a 30-minute or a 3-hour infusion) to determine which strategy provides a longer duration of plasma concentrations above the theoretical MIC of 2 mg/L. Participants will: Receive meropenem as part of their standard clinical care. Have blood samples collected during the first 48 hours of treatment to measure meropenem plasma concentrations. Have pharmacokinetic/pharmacodynamic parameters evaluated, including the percentage of time that meropenem concentrations remain above the theoretical target MIC. An exploratory objective of the study is to describe 28-day mortality and intensive care unit length of stay according to meropenem dose group.

NCT Number	NCT07681544
Lead Sponsor	Hospital Italiano de Buenos Aires
Conditions	Empirical Antimicrobial Therapy, Critically Ill, Meropenem, Pharmacokinetics and Pharmacodynamics
Enrollment	26 participants
Start Date	2024-06-26
Primary Completion	2024-09-20 (estimated)
Study Completion	2025-02-15 (estimated)
Updated on ClinicalTrials.gov	2026-07-08