NCT02096536

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

10.8 years

First QC Date

March 17, 2014

Last Update Submit

July 11, 2024

Conditions

Neonatal Infection

Keywords

NeonateVancomycinLC/MS-MSprotein binding

Outcome Measures

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.

    1 year

Secondary Outcomes (1)

  • Impact of freezing and thawing on vancomycin measurement

    1 year

Study Arms (1)

Vancomycin

OTHER

All included patients receive vancomycin for medical reasons. Decision for start of therapy is made by the treating physician.

Drug: Vancomycin

Interventions

VancomycinDRUG

vancomycin administration based on decision of treating physician

Also known as: Vancomycine Actavis
Vancomycin

Eligibility Criteria

Age1 Day - 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • No vancomycin therapy
  • No signed informed consent available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Anne Smits, MD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Smits, MD

CONTACT

003216341564anne.smits@uzleuven.be

Karel Allegaert, MD, PhD

CONTACT

003216343210karel.allegaert@uzleuven.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 26, 2014

Study Start

April 1, 2014

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

July 12, 2024

Record last verified: 2024-07

Locations

BE(1)