Clinical Study of Individualized Vancomycin Dosing Based on Population Pharmacokinetic Model for Severe Infections

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Admission to neurological intensive care unit (NICU).

• Age ≥18 years old. Participants will be eligible if they meet both of these criteria.

Locations
Other Locations
China
Central South University
RECRUITING
Changsha
Contact Information
Primary
Hainan Zhang, Doctor
hainanzhang@csu.edu.cn
13508474343
Backup
Xiaomei Wu, Doctor
wuxiaomei0923@csu.edu.cn
13873189804
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 112
Treatments
Experimental: experimental group
The experimental group will be guided by the population pharmacokinetics (PK) model for individual dosing of vancomycin.
Other: control group
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).
Related Therapeutic Areas
Sponsors
Leads: Central South University

This content was sourced from clinicaltrials.gov