Opt Vanc: Optimizing Vancomycin Therapy in Children
Study Details
Study Description
Brief 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.
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Detailed 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.
Study Design
Outcome Measures
Primary Outcome Measures
- 24-hour vancomycin AUC from optimally timed concentration [within 24-48 hours following enrollment]
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
Secondary Outcome Measures
- 24-hour vancomycin AUC estimated using all available vancomycin concentrations [within 24-48 hours following enrollment]
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
- 24-hour vancomycin AUC calculated using standard-of-care methods [within 24-48 hours following enrollment]
This 24-hour vancomycin AUC will be calculated using standard clinical methods (Zaske-Sawchuk method)
- Visit 2 vancomycin AUC using optimally timed concentration [24-72 hours after visit 1]
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
- Visit 2 vancomycin AUC using all available vancomycin concentrations [24-72 hours after visit 1]
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
- Visit 2 vancomycin AUC calculated using standard-of-care methods [24-72 hours after visit 1]
This 24-hour vancomycin AUC will be calculated using standard clinical methods (Zaske-Sawchuk method) based on measured concentrations at visit 2
- Vancomycin concentrations at Visits 1 and 2 [Days 1 to 5 of study participation]
Vancomycin concentrations will be measured by the Hospital Laboratory
Eligibility Criteria
Criteria
Inclusion Criteria:
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Administered intravenous vancomycin via intermittent infusion,
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Eligible for vancomycin AUC monitoring, per the subject's clinical team, and
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Parental/guardian permission (informed consent).
Exclusion Criteria:
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Receipt of renal replacement therapy, plasmapheresis, or extracorporeal membrane oxygenation (ECMO), or
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Unable to provide urine and blood samples.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Children's Hospital of Philadelphia
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-020240
- 5K23HD091365