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Trial record 5 of 528 for:    VANCOMYCIN

Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT03560440
Recruitment Status : Completed
First Posted : June 18, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Isabelle Spriet, Universitaire Ziekenhuizen Leuven

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
Gram-Positive Bacterial Infections 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.

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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 : June 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Loading dose related plasma exposure vancomycin [ Time Frame: 24 hours after loading dose ]
    Plasma exposure to vancomycin in relation to administered dose


Other Outcome Measures:
  1. Loading dose related plasma exposure vancomycin [ Time Frame: 24 hours after dosage adjustment ]
    Plasma exposure to vancomycin in relation to administered dose



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients treated with vancomycin and hospitalized in UZ Leuven between January 2012 and April 2014
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560440


Locations
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Belgium
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Isabel Spriet, PharmD PhD UZ Leuven

Publications:
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Responsible Party: Isabelle Spriet, PharmD PhD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03560440     History of Changes
Other Study ID Numbers: S56779
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Isabelle Spriet, Universitaire Ziekenhuizen Leuven:
Vancomycin
Pharmacokinetics
Trough level
Pediatric
Additional relevant MeSH terms:
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Bacterial Infections
Gram-Positive Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents