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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05691309
Other study ID # 22-020240
Secondary ID 5K23HD091365
Status Completed
Phase
First received
Last updated
Start date December 12, 2022
Est. completion date November 22, 2023

Study information

Verified date February 2024
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of Opt Vanc is to evaluate the feasibility of Bayesian dose adaptation, based on a previously-developed population pharmacokinetic (PK) model and a single optimally timed PK sample, to predict vancomycin area under the curve (AUC) in critically ill children.


Description:

Opt Vanc is an observational study of critically ill children prescribed IV vancomycin for a suspected infection at the Children's Hospital of Philadelphia. This study will evaluate how well Bayesian dose adaptation, based on a previously-developed population pharmacokinetic (PK) model for vancomycin and a single optimally timed vancomycin concentration, can predict vancomycin area under the curve (AUC) in critically ill children. Eligible subjects will be prescribed vancomycin and undergo routine therapeutic drug monitoring (TDM) per standard of care. At the time of TDM, each subject will have a vancomycin concentration obtained at the most informative sampling time to estimate AUC, as determined by the multiple-model optimal sampling function in PMetrics (population PK modeling program). Investigators will then compare the AUC determined using Bayesian estimation and the subject's optimally timed vancomycin concentration to the AUC determined using Bayesian estimation with all available concentrations (TDM samples plus the optimally timed sample). Investigators will also examine how AUC estimation compares to AUC calculated using standard-of-care methods (ie, log-linear equations). Further, Investigators will evaluate how well the population PK model, along with a subject's measured covariates and the optimally timed PK sample, can predict a subject's future vancomycin AUC.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date November 22, 2023
Est. primary completion date November 22, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Year to 17 Years
Eligibility Inclusion Criteria: - Administered intravenous vancomycin via intermittent infusion, - Eligible for vancomycin AUC monitoring, per the subject's clinical team, and - Parental/guardian permission (informed consent). Exclusion Criteria: - Receipt of renal replacement therapy, plasmapheresis, or extracorporeal membrane oxygenation (ECMO), or - Unable to provide urine and blood samples.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 24-hour vancomycin AUC from optimally timed concentration This 24-hour vancomycin AUC will be estimated using Bayesian estimation based on the population PK model, a subject's measured covariates and the optimally timed vancomycin concentration within 24-48 hours following enrollment
Secondary 24-hour vancomycin AUC estimated using all available vancomycin concentrations This 24-hour vancomycin AUC will be estimated using Bayesian estimation based on the population PK model, a subject's measured covariates and all available measured vancomycin concentrations within 24-48 hours following enrollment
Secondary 24-hour vancomycin AUC calculated using standard-of-care methods This 24-hour vancomycin AUC will be calculated using standard clinical methods (Zaske-Sawchuk method) within 24-48 hours following enrollment
Secondary Visit 2 vancomycin AUC using optimally timed concentration The predicted 24-hour vancomycin AUC at visit 2 will be estimated using Bayesian estimation based on the population PK model, a subject's measured covariates and the optimally timed vancomycin concentration at visit 1 24-72 hours after visit 1
Secondary Visit 2 vancomycin AUC using all available vancomycin concentrations The predicted 24-hour vancomycin AUC at visit 2 will be estimated using Bayesian estimation based on the population PK model, a subject's measured covariates and all available vancomycin concentrations 24-72 hours after visit 1
Secondary Visit 2 vancomycin AUC calculated using standard-of-care methods This 24-hour vancomycin AUC will be calculated using standard clinical methods (Zaske-Sawchuk method) based on measured concentrations at visit 2 24-72 hours after visit 1
Secondary Vancomycin concentrations at Visits 1 and 2 Vancomycin concentrations will be measured by the Hospital Laboratory Days 1 to 5 of study participation
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