Clinical Study of Individualized Vancomycin Dosing Based on Population PK Model

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central South University
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

1. Admission to neurological intensive care unit (NICU).

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

Exclusion Criteria:

1. Evidence of absolute renal impairment, which included Serum creatinine (SCR) ≥133 μmol/L at admission, development of acute kidney injury (AKI) after admission, need for renal replacement therapy during hospitalization, renal related tests suggestive of renal disease, and previous history of renal replacement therapy or chronic kidney disease.

2. Pregnant participants.

3. Primary diagnosis is non-neurological disease.

4. The height or weight of participants is not recorded in the medical record system.

5. The frequency of SCR monitoring was less than 3 times. Participants who meet any of these criteria will be excluded.