NCT05691309: Opt Vanc

Optimizing Vancomycin Therapy in Children

Completed Results posted Last updated 20 December 2024

What this trial tests

trial in Sepsis in 29 participants. Completed in 22 November 2023.

Timeline

12 December 2022

Primary endpoint
22 November 2023

22 November 2023

Quick facts

Lead sponsor	Children's Hospital of Philadelphia
Status	Completed
Study type	OBSERVATIONAL
Enrollment	29
Start date	12 December 2022
Primary completion	22 November 2023
Estimated completion	22 November 2023
Sites	1 location across United States

Conditions studied

• Sepsis — all drugs for Sepsis →
• Critical Illness — all drugs for Critical Illness →
• Infections — all drugs for Infections →
• Drug Toxicity — all drugs for Drug Toxicity →

Sponsor

Children's Hospital of Philadelphia

Who can join

Adults 1 to 17, any sex, with Sepsis or Critical Illness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Study Cohort	494	347 – 1008

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

Group	Value	95% CI
Study Cohort	495	336 – 1084

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

Group	Value	95% CI
Study Cohort	526	258 – 1111

Visit 2 Vancomycin Area Under the Curve (AUC) Using Optimally Timed Concentration Secondary · 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

Group	Value	95% CI
Study Cohort	500	326 – 668

Visit 2 Vancomycin Area Under the Curve (AUC) Using All Available Vancomycin Concentrations Secondary · 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

Group	Value	95% CI
Study Cohort	502	370 – 681

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

Group	Value	95% CI
Study Cohort	486	305 – 754

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Optimizing Vancomycin Therapy in Critically Ill Children: A Population Pharmacokinetics Study to Inform Vancomycin Area under the Curve Estimation Using Novel Biomarkers.
   Downes KJ, Zuppa AF, Sharova A, Neely MN. · · 2023 · cited 8× · PMID 37242578 · DOI 10.3390/pharmaceutics15051336
2. Multiple Model Optimal Sampling Promotes Accurate Vancomycin Area-Under-the-Curve Estimation Using a Single Sample in Critically Ill Children.
   Downes KJ, Sharova A, Malone J, Odom John AR, et al · · 2025 · cited 1× · PMID 39846757 · DOI 10.1097/ftd.0000000000001293