Clinical Study of Individualized Vancomycin Dosing Based on Population PK Model

NCT06161870 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2021SK53501
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Infection

Keywords

vancomycin; population pharmacokinetic model; severe infection

Outcome Measures

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.

  Half an hour before the fourth dose, and 1 hour after the end of the fourth dose

Secondary Outcomes (3)

• Mean scores of Acute Physiology and Chronic Health Evaluation (APACHE)Ⅱ after 2 weeks of vancomycin treatment

  After 2 weeks of vancomycin treatment

• Mean scores of Sequential Organ Failure Assessment (SOFA) after 2 weeks of vancomycin treatment

  After 2 weeks of vancomycin treatment

• Survival status (alive or dead) of participants at day 30 of hospitalization

  Day 30 of hospitalization

Study Arms (2)

experimental group

EXPERIMENTAL

The experimental group will be guided by the population pharmacokinetics (PK) model for individual dosing of vancomycin.

Drug: individualized vancomycin dosing based on the population pharmacokinetics (PK) model

control group

OTHER

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).

Drug: empirical vancomycin dosing

Interventions

individualized vancomycin dosing based on the population pharmacokinetics (PK) model DRUG

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.

experimental group

empirical vancomycin dosing DRUG

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).

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to neurological intensive care unit (NICU).
• Age ≥18 years old. Participants will be eligible if they meet both of these criteria.

You may not qualify if:

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

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Models, Biological

Intervention Hierarchy (Ancestors)

Models, Theoretical; Investigative Techniques

Study Officials

• Hainan Zhang, Doctor

  Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hainan Zhang, Doctor

CONTACT

13508474343; hainanzhang@csu.edu.cn

Xiaomei Wu, Doctor

CONTACT

13873189804; wuxiaomei0923@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the neurology department

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: December 8, 2023
• Study Start: January 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-11

Locations

CN (1)