Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT03560440
Collaborator
(none)
368
1
36
10.2

Study Details

Study Description

Brief Summary

In this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. Therefore data will be collected from all pediatric patients hospitalized in University Hospitals Leuven between January 2012 and April 2014 who were treated with vancomycine.

Condition or Disease Intervention/Treatment Phase
  • Other: Plasma exposure vancomycin

Detailed Description

In this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. Therefore data will be collected from all pediatric patients hospitalized in University Hospitals Leuven between January 2012 and April 2014 who were treated with vancomycine. Patient files will be screened for relevant information. Individual patients can be included multiple times if vancomycin has been administered more than once.

Study Design

Study Type:
Observational
Actual Enrollment :
368 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients
Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Plasma exposure vancomycin

Pediatric patients treated with vancomycin

Other: Plasma exposure vancomycin
Investigation of plasma exposure of vancomycin.

Outcome Measures

Primary Outcome Measures

  1. Loading dose related plasma exposure vancomycin [24 hours after loading dose]

    Plasma exposure to vancomycin in relation to administered dose

Other Outcome Measures

  1. Loading dose related plasma exposure vancomycin [24 hours after dosage adjustment]

    Plasma exposure to vancomycin in relation to administered dose

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Pediatric patients hospitalized in the University Hospitals Leuven between January 2012 and April 2014, treated with vancomycin
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Leuven Leuven Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

  • Principal Investigator: Isabel Spriet, PharmD PhD, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Isabelle Spriet, PharmD PhD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT03560440
Other Study ID Numbers:
  • S56779
First Posted:
Jun 18, 2018
Last Update Posted:
Jun 18, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Isabelle Spriet, PharmD PhD, Universitaire Ziekenhuizen Leuven
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2018