Study Comparing Personalized Vancomycin Dosing Using Population PK Model Versus Standard Empirical Dosing for Severe Infections in Neurological ICU Adults

What this Trial Is About

Researchers are evaluating whether individualized vancomycin dosing guided by a population pharmacokinetics PK model is more effective and safer than standard empirical dosing in adults with severe infections caused by gram-positive bacteria. This study involves participants admitted to a neurological intensive care unit with serious infections like bacteremia, sepsis, pneumonia, or meningitis. The trial aims to determine if dosing based on the PK model leads to better clinical outcomes compared to traditional dosing methods. Participants will be randomly assigned to one of two groups. The experimental group will receive vancomycin dosing individualized using a software tool that incorporates a validated PK model, which calculates dosing based on factors like age, gender, body weight, and kidney function to reach a specific pharmacodynamic target. The control group will receive empirical dosing of 15-20 mgkg vancomycin every 8-12 hours according to body weight. Vancomycin trough and peak concentrations will be measured once steady state is achieved, and pharmacokinetic parameters will be calculated using standard equations. During the study, researchers will collect detailed demographic and clinical data including kidney function tests, infection markers, severity scores, and outcomes at 30 and 90 days. They will also monitor vancomycin-related adverse effects and use of other nephrotoxic drugs. Data will be recorded carefully and analyzed to compare the clinical efficacy and safety of the two dosing approaches. The main outcome measured is the area under the plasma concentration curve over 24 hours AUC24 for vancomycin. The study plans to enroll 112 participants and will follow each through hospitalization and treatment.

Clinical Study of Individualized Vancomycin Dosing Based on Population PK Model