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

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ClinicalTrials.gov Identifier: NCT01418833
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : February 9, 2015
Sponsor:
Information provided by (Responsible Party):
Ap.r Kim Vanstraelen, Universitaire Ziekenhuizen Leuven

Brief Summary:
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.

Condition or disease
Patients Treated With Voriconazole

Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre.
Study Start Date : October 2010
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Voriconazole plasma levels during routine intravenous and oral therapy [ Time Frame: trough levels every 4 days after start or dose adjustment of voriconazole ]


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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
Patients treated with voriconazole, in whom at least 1 voriconazole plasma level was determined
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


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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): NCT01418833


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

Responsible Party: Ap.r Kim Vanstraelen, Hospital Pharmacist, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01418833     History of Changes
Other Study ID Numbers: ML7258
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: February 9, 2015
Last Verified: February 2015

Keywords provided by Ap.r Kim Vanstraelen, Universitaire Ziekenhuizen Leuven:
voriconazole
therapeutic drug monitoring
plasma levels
dose adjustment

Additional relevant MeSH terms:
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors