CompletedNot Applicable

Optimizing Vancomycin Therapy in Children

United States29 participantsStarted 2022-12-12

Plain-language 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.

Who can participate

Age range1 Year – 17 Years

SexALL

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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.

What they're measuring

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

Timeframe: within 24-48 hours following enrollment

Trial details

NCT IDNCT05691309

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-11-22

Results submitted2024-11-20

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