Exploring Vancomycin Disposition in Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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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

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Neonatal Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vancomycin

All included patients receive vancomycin for medical reasons. Decision for start of therapy is made by the treating physician.

Group Type OTHER

Vancomycin

Intervention Type DRUG

vancomycin administration based on decision of treating physician

Interventions

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Vancomycin

vancomycin administration based on decision of treating physician

Intervention Type DRUG

Other Intervention Names

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Vancomycine Actavis

Eligibility Criteria

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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.