Exploring Vancomycin Disposition in Neonates

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Neonatal Infection

Intervention / Treatment
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* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 23 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonate, Vancomycin, LC/MS-MS, protein binding