Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre

This study has been completed.
Information provided by (Responsible Party):
Ap.r Kim Vanstraelen, Universitaire Ziekenhuizen Leuven Identifier:
First received: August 16, 2011
Last updated: February 6, 2015
Last verified: February 2015
The first goal of this study is to map all the subtherapeutic, therapeutic and supratherapeutic voriconazole plasma levels in the University Hospitals Leuven. The second objective is to optimize and validate guidelines for dose modifications in patients with too low or high plasma concentrations and to investigate if the same guidelines can be used in different patient populations.

Patients Treated With Voriconazole

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre.

Resource links provided by NLM:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Voriconazole plasma levels during routine intravenous and oral therapy [ Time Frame: trough levels every 4 days after start or dose adjustment of voriconazole ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: October 2010
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with voriconazole, in whom at least 1 voriconazole plasma level was determined

Inclusion Criteria:

  • Patients treated with voriconazole
  • at least 1 voriconazole plasma level measured during therapy

Exclusion Criteria:

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Please refer to this study by its identifier: NCT01418833

University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Kim Vanstraelen, R.Ph. Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
  More Information

Responsible Party: Ap.r Kim Vanstraelen, Hospital Pharmacist, Universitaire Ziekenhuizen Leuven Identifier: NCT01418833     History of Changes
Other Study ID Numbers: ML7258 
Study First Received: August 16, 2011
Last Updated: February 6, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
therapeutic drug monitoring
plasma levels
dose adjustment

Additional relevant MeSH terms:
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on May 01, 2016