Exploring Vancomycin Disposition in Neonates

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

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

  • Drug: Vancomycin
    • vancomycin administration based on decision of treating physician

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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 .

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 23 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen KU Leuven
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anne Smits, MD, Principal Investigator, UZ Leuven
  • Overall Contact(s)
    • Anne Smits, MD, 003216341564, anne.smits@uzleuven.be

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.