Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre
Verified March 2013 by Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Ap.r Kim Vanstraelen, Universitaire Ziekenhuizen Leuven
First received: August 16, 2011
Last updated: March 1, 2013
Last verified: March 2013
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
||Observational Model: Case-Only
Time Perspective: Prospective
||Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre.
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:
| Study Start Date:
| Estimated Primary Completion Date:
||October 2013 (Final data collection date for primary outcome measure)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients treated with voriconazole, in whom at least 1 voriconazole plasma level was determined
- Patients treated with voriconazole
- at least 1 voriconazole plasma level measured during therapy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01418833
|University Hospitals Leuven
|Leuven, Vlaams-Brabant, Belgium, 3000 |
|Principal Investigator: Kim Vanstraelen, R.Ph. |
|Sub-Investigator: Isabel Spriet, Pharm.D. |
|Sub-Investigator: Ludo Willems, Professor |
Universitaire Ziekenhuizen Leuven
||Kim Vanstraelen, R.Ph.
||Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
No publications provided
||Ap.r Kim Vanstraelen, Hospital Pharmacist, Universitaire Ziekenhuizen Leuven
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 16, 2011
||March 1, 2013
||Belgium: Federal Agency for Medicinal Products and Health Products
Keywords provided by Universitaire Ziekenhuizen Leuven:
therapeutic drug monitoring
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 15, 2014
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