Prospective evaluation of individualized vancomycin dosing based on a population pharmacokinetic model in patients with severe Gram-positive bacterial infection.

Background: The population pharmacokinetic (PK) modeling of vancomycin has been validated to accurately predict concentration-time data in sepsis patients, but its effectiveness in clinical practice remains uncertain. This study aims to evaluate the clinical utility of individualized vancomycin dosing guided by a population PK model in patients with severe infections. Methods: This was a single-center, randomized, single-blind, controlled clinical trial. A total of 54 participants with severe infections caused by suspected or confirmed Gram-positive bacteria, who received vancomycin treatment during hospitalization, were prospectively included and identified as eligible. Participants were randomly allocated to either the individualized dosing group guided by a population PK model (n = 28) or the empirical dosing group (n = 26). After a 2-week treatment period, comparisons were made regarding pharmacokinetics/pharmacodynamics (PK/PD) target attainment, clinical efficacy, and safety between the two groups. Results: The individualized dosing group achieved an area under the concentration curve (AUC Conclusion: A daily dosage of individualized administration guided by a population PK model results in improved attainment rates for PK/PD targets and enhanced clinical efficacy without an increased risk of drug-related adverse reactions. Clinical Trial Registration: https://clinicaltrials.gov/study/NCT06161870, identifier NCT06161870.