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

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.

Study Overview

• Status: Unknown
• Conditions: Neonatal Infection
• Intervention / Treatment: Drug: Vancomycin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anne Smits, MD; Phone Number: 003216341564; Email: anne.smits@uzleuven.be
• Study Contact Backup: Name: Karel Allegaert, MD, PhD; Phone Number: 003216343210; Email: karel.allegaert@uzleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven
      • Contact: Anne Smits, MD; Phone Number: 003216341564; Email: anne.smits@uzleuven.be
      • Contact: Karel Allegaert, MD,PhD; Phone Number: 003216343210; Email: karel.allegaert@uzleuven.be
      • Sub-Investigator: Karel Allegaert, MD, PhD
      • Principal Investigator: Anne Smits, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vancomycin; All included patients receive vancomycin for medical reasons. Decision for start of therapy is made by the treating physician.	Drug: Vancomycin; vancomycin administration based on decision of treating physician; Other Names: Vancomycine Actavis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Anne Smits, MD, UZ Leuven

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: March 17, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: November 2, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Vancomycin; Neonate; protein binding; LC/MS-MS
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: S56376