Exploring Vancomycin Disposition in Neonates
Recruiting
Phase 4
Interventional Study
Neonatal Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Day – 23 Months
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 120 (estimated)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Other
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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 bindi…
Trial Locations
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Eligibility 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
Contacts