Clinical Study of Individualized Vancomycin Dosing Based on Population PK Model

Condition(s) studied

Investigational drug(s) / intervention(s)

individualized vancomycin dosing based on the population pharmacokinetics (PK) model: The experimental group will be guided at the bedside with individualized vancomycin dosing by a drug dosimetry software tool that incorporates a PK model developed by Roberts JA et al. for data from sepsis patients. The model developed by Roberts JA et al. has been validated in multiple centers to have a good ability to predict the concentration-time data of patients. Once the basic information of participants such as gender, age, body weight, and creatinine clearance rate (CCR) is entered, the software tool can calculate the dosing regimen that is estimated to achieve the pharmacodynamic (PD) target. The area under the curve (AUC24) of 400-600mg·h/L is identified as the PD target of vancomycin.

empirical vancomycin dosing: The control group will be administered empirically (15-20 mg/kg vancomycin infused intermittently every 8-12 hours depending on the actual body weight of participants).

Study summary

The goal of this clinical trial is to compare the clinical efficacy of individualized dosing based on the population pharmacokinetics (PK) model and empirical dosing of vancomycin in participants with severe infections.

It aims to answer whether individual vancomycin dosing based on population PK model is superior to empirical dosing in terms of clinical efficacy and safety.

Participants will be randomly divided into experimental group and control group. The experimental group will be guided by the population PK model for individual dosing, and the control group will be given empirical dosing. Demographic data, clinical characteristics of participants, and their trough concentrations (Cmin) and peak concentrations (Cmax) of vancomycin will be collected. Area under the concentration curve (AUC24) of participants will be calculated using the first-order PK equation.

Researchers will compare experimental group and control group to see if individual vancomycin dosing based on population PK model is superior to empirical dosing in terms of clinical efficacy and safety.

Eligibility

Primary outcome measure(s)

• Area under the Plasma Concentration versus Time Curve within 24 hours (AUC24) of vancomycin — Half an hour before the fourth dose, and 1 hour after the end of the fourth dose
  After three consecutive doses of vancomycin, trough concentration (Cmin) will be measured by blood sampling half an hour before the fourth dose, and peak concentration (Cmax) will be measured by blood sampling 1 hour after the end of the fourth dose to calculate AUC24.

Trial sites (1)

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