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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02096536

Enrollment

120

Registered

2014-03-26

Start date

2014-04-30

Completion date

2025-01-31

Last updated

2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Infection

Keywords

Neonate, Vancomycin, LC/MS-MS, protein binding

Brief 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.

Interventions

DRUGVancomycin

vancomycin administration based on decision of treating physician

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 23 Months

Healthy volunteers

Inclusion criteria

* Neonates, admitted to the Neonatal Intensive Care Unit to whom vancomycin is administered for medical reasons, can be included in the study after informed consent of the parents.

Exclusion criteria

* No vancomycin therapy * No signed informed consent available

Design outcomes

Primary

Measure	Time frame	Description
Differences in vancomycin exposure	1 year	Paired vancomycin concentrations in 60 neonates using an immunoassay versus LC/MS-MS method. Total versus unbound vancomycin concentrations in 60 neonates.

Secondary

Measure	Time frame	Description
Impact of freezing and thawing on vancomycin measurement	1 year	Comparisson of the same analytical technique (immunoassay) in fresh (routine clinical care) versus stored samples .

Countries

Belgium

Contacts

Primary ContactAnne Smits, MD

anne.smits@uzleuven.be003216341564

Backup ContactKarel Allegaert, MD, PhD

karel.allegaert@uzleuven.be003216343210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026