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
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