Exploring Vancomycin Disposition in Neonates

Neonatal Infection Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02096536
• Other study ID #: S56376
• Status: Recruiting
• Phase: Phase 4
• First received: March 17, 2014
• Last updated: November 2, 2015
• Start date: April 2014
• Est. completion date: January 2016

Study information

• Verified date: November 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Anne Smits, MD
• Phone: 003216341564
• Email: anne.smits[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 23 Months

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Neonatal Infection

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No