A Phase 4 interventional study of Vancomycin in Neonatal Infection, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 1 Day to 23 Months. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 4, Interventional, and Basic science
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.
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.
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All included patients receive vancomycin for medical reasons. Decision for start of therapy is made by the treating physician.
Drug: Vancomycin
vancomycin administration based on decision of treating physician
Also known as: Vancomycine Actavis
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.
Time frame: 1 year
Impact of freezing and thawing on vancomycin measurement
Comparisson of the same analytical technique (immunoassay) in fresh (routine clinical care) versus stored samples .
Time frame: 1 year
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Universitaire Ziekenhuizen KU Leuven