ClinicalTrials.gg
Sign In
CompletedNCT01418833Updated Feb 9, 2015

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

An observational study in Patients Treated With Voriconazole, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2015-02-09.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
160
Sex
All
01

Study 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.

02

Conditions studied

  • Patients Treated With Voriconazole

Keywords

  • voriconazole
  • therapeutic drug monitoring
  • plasma levels
  • dose adjustment
03

In context

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 959 studies on the registry; 263 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Universitaire Ziekenhuizen KU Leuven studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
160 participants (actual)
06

What researchers measure

Primary outcomes

  1. Voriconazole plasma levels during routine intravenous and oral therapy

    Time frame: trough levels every 4 days after start or dose adjustment of voriconazole

07

Study locations

1 site
  • University Hospitals Leuven
    Leuven, Vlaams-Brabant 3000, Belgium
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2010, a primary completion of Jan 2015 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2011
First posted
Aug 17, 2011
Start
Oct 2010
Primary completionActual
Jan 2015
CompletionActual
Jan 2015
Last update
Feb 9, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01418833
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Ap.r Kim Vanstraelen (Hospital Pharmacist, Universitaire Ziekenhuizen KU Leuven) — Principal investigator
First posted
Aug 17, 2011
Start date
Oct 2010
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Feb 9, 2015

Study contacts

Kim Vanstraelen, R.Ph.
principal investigator · Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Universitaire Ziekenhuizen KU Leuven →

Start the discussion