Clinical trial NCT05691309: Optimizing Vancomycin Therapy in Children
Official title: Optimizing Vancomycin Therapy in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Critical Illness
Infections
Drug Toxicity
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-01-20
Enrollment: 29
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants aged 1-17 years receiving standard of care IV vancomycin for a suspected or confirmed infection will be enrolled at Children's Hospital of Philadelphia.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 24-hour Vancomycin Area Under the Curve (AUC) From Optimally Timed Concentration
timeFrame: within 24-48 hours following enrollment
Secondary outcomes:
measure: 24-hour Vancomycin Area Under the Curve (AUC) Estimated Using All Available Vancomycin Concentrations
timeFrame: within 24-48 hours following enrollment
measure: 24-hour Vancomycin Area Under the Curve (AUC) Calculated Using Standard-of-care Methods
timeFrame: within 24-48 hours following enrollment
measure: Visit 2 Vancomycin Area Under the Curve (AUC) Using Optimally Timed Concentration
timeFrame: 24-72 hours after visit 1
measure: Visit 2 Vancomycin Area Under the Curve (AUC) Using All Available Vancomycin Concentrations
timeFrame: 24-72 hours after visit 1
measure: Visit 2 Vancomycin Area Under the Curve (AUC) Calculated Using Standard-of-care Methods
timeFrame: 24-72 hours after visit 1
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
References: