Exploring Vancomycin Disposition in Neonates
ConditionNeonatal Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-23
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
No vancomycin therapy
No signed informed consent available
Trial design
Design model
Single group
Treatments tested in this trial
Vancomycin
Drugvancomycin administration based on decision of treating physician
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: VancomycinOther 1 intervention
Trial outcomes
Primary outcomes
1
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 yearSecondary outcomes
1
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 yearSponsors and contacts
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Source ClinicalTrials.gov