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Exploring Vancomycin Disposition in Neonates

Information source: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neonatal Infection

Intervention: Vancomycin (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Universitaire Ziekenhuizen Leuven

Official(s) and/or principal investigator(s):
Anne Smits, MD, Principal Investigator, Affiliation: UZ Leuven

Overall contact:
Anne Smits, MD, Phone: 003216341564, Email: anne.smits@uzleuven.be

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.

Clinical Details

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

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

Primary outcome: Differences in vancomycin exposure

Secondary outcome: Impact of freezing and thawing on vancomycin measurement

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.

Eligibility

Minimum age: N/A. Maximum age: 23 Months. Gender(s): Both.

Criteria:

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

Locations and Contacts

Anne Smits, MD, Phone: 003216341564, Email: anne.smits@uzleuven.be

UZ Leuven, Leuven, Vlaams-Brabant 3000, Belgium; Not yet recruiting
Anne Smits, MD, Phone: 003216341564, Email: anne.smits@uzleuven.be
Karel Allegaert, MD,PhD, Phone: 003216343210, Email: karel.allegaert@uzleuven.be
Karel Allegaert, MD, PhD, Sub-Investigator
Anne Smits, MD, Principal Investigator
Additional Information

Starting date: April 2014
Last updated: March 21, 2014

Page last updated: August 23, 2015

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