Examining how vancomycin behaves in newborns
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
This study is testing how vancomycin works in newborns by comparing different ways to measure its levels in their blood and looking at how it binds to proteins in their bodies.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 1 Day to 23 Months |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT02096536 on ClinicalTrials.gov |
What this trial studies
This study investigates the disposition of vancomycin in neonates by comparing serum vancomycin concentrations measured through an immunoassay with those obtained from a reference liquid chromatography-tandem mass spectrometry method. Additionally, it aims to assess the protein binding of vancomycin and identify factors that may influence this binding in neonates. The research is conducted in a Neonatal Intensive Care Unit setting, where neonates receiving vancomycin for medical reasons will be enrolled after obtaining informed consent from their parents.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates admitted to the Neonatal Intensive Care Unit who are prescribed vancomycin.
Not a fit: Patients who are not receiving vancomycin therapy or whose parents do not provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of vancomycin dosing and effectiveness in neonates, leading to improved treatment outcomes.
How similar studies have performed: While vancomycin has been used in neonates for decades, this specific analysis of its disposition and protein binding is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Anne Smits, MD — UZ Leuven
- Study coordinator: Anne Smits, MD
- Email: anne.smits@uzleuven.be
- Phone: 003216341564
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.