Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients

June 6, 2018 updated by: Isabelle Spriet, Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

368

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients treated with vancomycin and hospitalized in UZ Leuven between January 2012 and April 2014

Description

Inclusion Criteria:

  • Pediatric patients hospitalized in the University Hospitals Leuven between January 2012 and April 2014, treated with vancomycin

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Plasma exposure vancomycin
Pediatric patients treated with vancomycin
Other: Plasma exposure vancomycin
Investigation of plasma exposure of vancomycin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loading dose related plasma exposure vancomycin
Time Frame: 24 hours after loading dose
Plasma exposure to vancomycin in relation to administered dose
24 hours after loading dose

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loading dose related plasma exposure vancomycin
Time Frame: 24 hours after dosage adjustment
Plasma exposure to vancomycin in relation to administered dose
24 hours after dosage adjustment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

June 6, 2018

First Posted (ACTUAL)

June 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2018

Last Update Submitted That Met QC Criteria

June 6, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S56779

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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