Clinical trial
Clinical Study of Individualized Vancomycin Dosing Based on Population Pharmacokinetic Model for Severe Infections
Name
2021SK53501
Description
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.
Trial arms
Trial start
2021-01-01
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
experimental group
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).
Arms:
control group
Size
112
Primary endpoint
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
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 112, 'type': 'ESTIMATED'}}
Updated at
2023-12-08
1 organization
2 products
1 indication
Organization
Central South UniversityIndication
Severe InfectionProduct
Empirical Vancomycin