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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01418833
Other study ID # ML7258
Secondary ID
Status Completed
Phase N/A
First received August 16, 2011
Last updated February 6, 2015
Start date October 2010
Est. completion date January 2015

Study information

Verified date February 2015
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients treated with voriconazole

- at least 1 voriconazole plasma level measured during therapy

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Patients Treated With Voriconazole

Locations

Country Name City State
Belgium University Hospitals Leuven Leuven Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Voriconazole plasma levels during routine intravenous and oral therapy trough levels every 4 days after start or dose adjustment of voriconazole No