Clinical Study of Individualized Vancomycin Dosing Based on Population PK Model

PHASE4RecruitingINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

January 1, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Severe Infection
Interventions
DRUG

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.

DRUG

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).

Trial Locations (1)

410000

RECRUITING

Central South University, Changsha

All Listed Sponsors
lead

Central South University

OTHER