Exploring Vancomycin Disposition in Neonates
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|ClinicalTrials.gov Identifier: NCT02096536|
Recruitment Status : Unknown
Verified November 2015 by Universitaire Ziekenhuizen Leuven.
Recruitment status was: Recruiting
First Posted : March 26, 2014
Last Update Posted : November 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Infection||Drug: Vancomycin||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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 Start Date :||April 2014|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2016|
All included patients receive vancomycin for medical reasons. Decision for start of therapy is made by the treating physician.
vancomycin administration based on decision of treating physician
Other Name: Vancomycine Actavis
- Differences in vancomycin exposure [ Time Frame: 1 year ]
Paired vancomycin concentrations in 60 neonates using an immunoassay versus LC/MS-MS method.
Total versus unbound vancomycin concentrations in 60 neonates.
- Impact of freezing and thawing on vancomycin measurement [ Time Frame: 1 year ]Comparisson of the same analytical technique (immunoassay) in fresh (routine clinical care) versus stored samples .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096536
|Contact: Anne Smits, MDemail@example.com|
|Contact: Karel Allegaert, MD, PhDfirstname.lastname@example.org|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Contact: Anne Smits, MD 003216341564 email@example.com|
|Contact: Karel Allegaert, MD,PhD 003216343210 firstname.lastname@example.org|
|Sub-Investigator: Karel Allegaert, MD, PhD|
|Principal Investigator: Anne Smits, MD|
|Principal Investigator:||Anne Smits, MD||UZ Leuven|