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OpenTrials
Completed

NCT Number: NCT05691309

Optimizing Vancomycin Therapy in Children

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.

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Key information

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 24-hour Vancomycin Area Under the Curve (AUC) From Optimally Timed Concentration

    Time frame: within 24-48 hours following enrollment

    This 24-hour vancomycin area under the curve (AUC) will be estimated using Bayesian estimation based on the population pharmacokinetic (PK) model, a subject's measured covariates and the optimally timed vancomycin concentration

Secondary outcomes

  1. 24-hour Vancomycin Area Under the Curve (AUC) Estimated Using All Available Vancomycin Concentrations

    Time frame: within 24-48 hours following enrollment

    This 24-hour vancomycin area under the curve (AUC) will be estimated using Bayesian estimation based on the population pharmacokinetic (PK) model, a subject's measured covariates and all available measured vancomycin concentrations

  2. 24-hour Vancomycin Area Under the Curve (AUC) Calculated Using Standard-of-care Methods

    Time frame: within 24-48 hours following enrollment

    This 24-hour vancomycin area under the curve (AUC) will be calculated using standard clinical methods (Zaske-Sawchuk method)

  3. Visit 2 Vancomycin Area Under the Curve (AUC) Using Optimally Timed Concentration

    Time frame: 24-72 hours after visit 1

    The predicted 24-hour vancomycin area under the curve (AUC) at visit 2 will be estimated using Bayesian estimation based on the population pharmacokinetic (PK) model, a subject's measured covariates and the optimally timed vancomycin concentration at visit 1

  4. Visit 2 Vancomycin Area Under the Curve (AUC) Using All Available Vancomycin Concentrations

    Time frame: 24-72 hours after visit 1

    The predicted 24-hour vancomycin area under the curve (AUC) at visit 2 will be estimated using Bayesian estimation based on the population pharmacokinetic (PK) model, a subject's measured covariates and all available vancomycin concentrations

  5. Visit 2 Vancomycin Area Under the Curve (AUC) Calculated Using Standard-of-care Methods

    Time frame: 24-72 hours after visit 1

    This 24-hour vancomycin area under the curve (AUC) will be calculated using standard clinical methods (Zaske-Sawchuk method) based on measured concentrations at visit 2

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: Opt Vanc

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2023
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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