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NCT Number: NCT02096536

Exploring Vancomycin Disposition in Neonates

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.

Recruiting

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Key information

Conditions

Neonatal Infection

Age range

1 day–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancomycin

Drug

vancomycin administration based on decision of treating physician

Other names: Vancomycine Actavis

Primary outcomes

  1. Differences in vancomycin exposure

    Time frame: 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 outcomes

  1. Impact of freezing and thawing on vancomycin measurement

    Time frame: 1 year

    Comparisson of the same analytical technique (immunoassay) in fresh (routine clinical care) versus stored samples .

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Smits, MD

CONTACT

[email protected]

003216341564

Karel Allegaert, MD, PhD

CONTACT

[email protected]

003216343210

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2014
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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