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COMPLETED
NCT07681544
NA

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

Sponsor: Hospital Italiano de Buenos Aires

View on ClinicalTrials.gov

Summary

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 question sit 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.

Official title: Meropenem Dosing in Critically Ill Patients: Early Evaluation of Plasma Concentrations and Minimum Inhibitory Concentration

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2024-06-26

Completion Date

2025-02-15

Last Updated

2026-07-02

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Blood extraction

Blood samples of 5 ml were collected within the interdose interval. Sample collection times varied among subjects, ensuring coverage of at least one sample every 30 minutes after administration of 1 g or 2 g of meropenem. After collection, samples were immediately transferred to the laboratory and stored at -80 °C until analysis.

Locations (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina