Exploring Vancomycin Disposition in Neonates

Phase 4

Recruiting

• Conditions: Neonatal Infection
• Interventions: Drug: Vancomycin

• Registration Number: NCT02096536
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

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 Timeline

• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Study Start: 2014-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Differences in vancomycin exposure	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 Outcome Measures

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

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium