Clinical Study of Individualized Vancomycin Dosing Based on Population PK Model
ConditionSevere Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral South University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Admission to neurological intensive care unit (NICU).
Age ≥18 years old. Participants will be eligible if they meet both of these criteria.
Disqualifiers
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.
Pregnant participants.
Primary diagnosis is non-neurological disease.
The height or weight of participants is not recorded in the medical record system.
Trial design
Design model
Parallel
Treatments tested in this trial
individualized vancomycin dosing based on the population pharmacokinetics (PK) model
DrugThe 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.
empirical vancomycin dosing
DrugThe 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).
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: experimental groupExperimental treatment 1 intervention
Group B: control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Area under the Plasma Concentration versus Time Curve within 24 hours (AUC24) of vancomycin
After three consecutive doses of vancomycin, trough concentration (Cmin) will be measured by blood sampling half an hour before the fourth dose, and peak concentration (Cmax) will be measured by blood sampling 1 hour after the end of the fourth dose to calculate AUC24.
Time frame
Half an hour before the fourth dose, and 1 hour after the end of the fourth doseSecondary outcomes
1
Mean scores of Acute Physiology and Chronic Health Evaluation (APACHE)Ⅱ after 2 weeks of vancomycin treatment
After 2 weeks of vancomycin treatment, APACHEⅡ of each participant will be collected to calculate mean scores.
Time frame
After 2 weeks of vancomycin treatment2
Mean scores of Sequential Organ Failure Assessment (SOFA) after 2 weeks of vancomycin treatment
After 2 weeks of vancomycin treatment, SOFA of each participant will be collected to calculate mean scores.
Time frame
After 2 weeks of vancomycin treatment3
Survival status (alive or dead) of participants at day 30 of hospitalization
The survival status (alive or dead) of each participant will be recorded at day 30 of hospitalization.
Time frame
Day 30 of hospitalizationSponsors and contacts
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Source ClinicalTrials.gov