Optimizing Vancomycin Therapy in Children

Sepsis Clinical Trial

— Opt Vanc  

Official title:

Optimizing Vancomycin Therapy in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05691309
• Other study ID #: 22-020240
• Secondary ID: 5K23HD091365
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Critical Illness
• Drug Toxicity
• Drug-Related Side Effects and Adverse Reactions
• Infections
• Sepsis

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