Actively Recruiting
Clinical Study of Individualized Vancomycin Dosing Based on Population PK Model
Led by Central South University · Updated on 2023-12-08
112
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study of Individualized Vancomycin Dosing Based on Population PK Model
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admission to neurological intensive care unit (NICU)
- Age 18 years or older
You will not qualify if you...
- Evidence of absolute renal impairment, including serum creatinine 6 133 bcmol/L at admission, acute kidney injury after admission, need for renal replacement therapy, or history of renal disease
- Pregnant participants
- Primary diagnosis is non-neurological disease
- Height or weight not recorded in medical records
- Serum creatinine monitoring less than 3 times
AI-Screening
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Trial Site Locations
Total: 1 location
1
Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
Research Team
H
Hainan Zhang, Doctor
CONTACT
X
Xiaomei Wu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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