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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Ap.r Kim Vanstraelen, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01418833
First received: August 16, 2011
Last updated: March 1, 2013
Last verified: March 2013
  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 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 ]

Estimated Enrollment: 300
Study Start Date: October 2010
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
  Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418833

Contacts
Contact: Kim Vanstraelen, R.Ph. (+32) (0)16 342339 kim.vanstraelen@uzleuven.be
Contact: Isabel Spriet, Pharm.D. isabel.spriet@uzleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Principal Investigator: Kim Vanstraelen, R.Ph.         
Sub-Investigator: Isabel Spriet, Pharm.D.         
Sub-Investigator: Ludo Willems, Professor         
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

No publications provided

Responsible Party: Ap.r Kim Vanstraelen, Hospital Pharmacist, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01418833     History of Changes
Other Study ID Numbers: ML7258
Study First Received: August 16, 2011
Last Updated: March 1, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

Additional relevant MeSH terms:
Voriconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014