NCT02096536 Exploring Vancomycin Disposition in Neonates
| NCT ID | NCT02096536 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Neonatal Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2014-04 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2014-04 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Anne Smits, MD
PRINCIPAL INVESTIGATOR
UZ Leuven
Frequently Asked Questions
Who can join the NCT02096536 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 23 Months, studying Neonatal Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02096536 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT02096536 currently recruiting?
Yes, NCT02096536 is actively recruiting participants. Contact the research team at anne.smits@uzleuven.be for enrollment information.
Where is the NCT02096536 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT02096536 clinical trial?
NCT02096536 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Anne Smits, MD at UZ Leuven. The trial plans to enroll 120 participants.