Optimizing Vancomycin Therapy in Children

NCT05691309 | Completed Results

• 2 other identifiers: 22-0202405K23HD091365
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Critical Illness; Infections; Drug Toxicity

Outcome Measures

Primary Outcomes (1)

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

  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

  within 24-48 hours following enrollment

Secondary Outcomes (5)

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

  within 24-48 hours following enrollment

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

  within 24-48 hours following enrollment

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

  24-72 hours after visit 1

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

  24-72 hours after visit 1

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

  24-72 hours after visit 1

Study Arms (1)

Study Cohort

Recipients of vancomycin

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Administered intravenous vancomycin via intermittent infusion,
• Eligible for vancomycin AUC monitoring, per the subject's clinical team, and
• Parental/guardian permission (informed consent).

You may not qualify if:

• Receipt of renal replacement therapy, plasmapheresis, or extracorporeal membrane oxygenation (ECMO), or
• Unable to provide urine and blood samples.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Downes KJ, Sharova A, Malone J, Odom John AR, Zuppa AF, Neely MN. Multiple Model Optimal Sampling Promotes Accurate Vancomycin Area-Under-the-Curve Estimation Using a Single Sample in Critically Ill Children. Ther Drug Monit. 2025 Jan 23;47(4):512-519. doi: 10.1097/FTD.0000000000001293.

  PMID: 39846757 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and plasma

MeSH Terms

Conditions

Sepsis; Critical Illness; Infections; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Chemically-Induced Disorders

Results Point of Contact

• Title: Dr. Kevin Downes
• Organization: Children's Hospital of Philadelphia

downeskj@chop.edu

215-590-4024

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 20, 2023
• Study Start: December 12, 2022
• Primary Completion: November 22, 2023
• Study Completion: November 22, 2023
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)