We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01418833
First Posted: August 17, 2011
Last Update Posted: February 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ap.r Kim Vanstraelen, Universitaire Ziekenhuizen Leuven
  Purpose
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
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 Ap.r Kim Vanstraelen, 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 ]

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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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:

  Contacts and Locations
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): 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
  More Information

Responsible Party: Ap.r Kim Vanstraelen, Hospital Pharmacist, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01418833     History of Changes
Other Study ID Numbers: ML7258
First Submitted: August 16, 2011
First Posted: August 17, 2011
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