NCT02096536

Exploring Vancomycin Disposition in Neonates

Exploring Vancomycin Disposition in Neonates: Paired Analysis of Vancomycin Concentrations Using Immunoassay and Liquid-chromatography-tandem Mass Spectrometry. Determination of Vancomycin Protein Binding and Its Covariates in Neonates

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 1 Day – 23 Months
• Healthy volunteers: Not accepted

Summary

Vancomycin is already used for decades in neonates. However, there are remaining questions concerning vancomycin disposition in this population. The purpose of this study is first of all to perform a paired analysis of serum vancomycin concentrations using an immunoassay versus a reference liquid chromatography-tandem mass spectrometry method. Secondly, we aim to determine vancomycin protein binding and its covariates in neonates.

Detailed description

Exploration of vancomycin disposition in neonates: Objective 1: Paired analysis of (total) serum vancomycin concentrations in neonates using the currently available immunoassay (Cobas c702) versus a reference liquid chromatography-tandem mass spectrometry method (LC-MS/MS). Objective 2: The determination of vancomycin protein binding and its covariates in neonates.

Conditions

• Neonatal Infection

Interventions

Type	Name	Description
DRUG	Vancomycin	vancomycin administration based on decision of treating physician

Timeline

• Start date: 2014-04-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2014-03-26
• Last updated: 2024-07-12

Locations

1 site across 1 country: Belgium