N/A
Completed N=22
Optimizing Vancomycin Therapy in Children
Source: ClinicalTrials.gov NCT05691309 ↗Enrolled (actual)
22
Serious AEs
—
Results posted
Dec 2024
Primary outcomePrimary: 24-hour Vancomycin Area Under the Curve (AUC) From Optimally Timed Concentration — 494 mg*hr/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24-hour Vancomycin Area Under the Curve (AUC) From Optimally Timed Concentration |
494 | — |
| SECONDARY 24-hour Vancomycin Area Under the Curve (AUC) Estimated Using All Available Vancomycin Concentrations |
495 | — |
| SECONDARY 24-hour Vancomycin Area Under the Curve (AUC) Calculated Using Standard-of-care Methods |
526 | — |
| SECONDARY Visit 2 Vancomycin Area Under the Curve (AUC) Using Optimally Timed Concentration |
500 | — |
| SECONDARY Visit 2 Vancomycin Area Under the Curve (AUC) Using All Available Vancomycin Concentrations |
502 | — |
| SECONDARY Visit 2 Vancomycin Area Under the Curve (AUC) Calculated Using Standard-of-care Methods |
486 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05691309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.