Patients Treated With VoriconazoleNCT01418833
Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre
An observational study of Patients Treated With Voriconazole, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients Treated With Voriconazole
- How many people
- 160 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2010to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with voriconazole, in whom at least 1 voriconazole plasma level was determined
Who may be able to join
- Patients treated with voriconazole
- at least 1 voriconazole plasma level measured during therapy
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre.
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.
- Conditions
- Patients Treated With Voriconazole
- Keywords
- voriconazole, therapeutic drug monitoring, plasma levels, dose adjustment
What is being measured
The primary outcome is the main question the study is designed to answer.
Voriconazole plasma levels during routine intravenous and oral therapy
Measured: trough levels every 4 days after start or dose adjustment of voriconazole
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startOct 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Treated With VoriconazoleStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ap.r Kim Vanstraelen, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Kim Vanstraelen, R.Ph., Principal investigator, Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418833
- Sponsor's protocol ID
- ML7258
- Status last verified
- Feb 2015
- First submitted
- 16 Aug 2011
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre.
- ClinicalTrials.gov ID
- NCT01418833
- Acronym / sponsor ID
- ML7258
- Conditions
- Patients Treated With Voriconazole
- Keywords
- voriconazole, therapeutic drug monitoring, plasma levels, dose adjustment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with voriconazole, in whom at least 1 voriconazole plasma level was determined
Key inclusion criteria (2 listed)
- Patients treated with voriconazole
- at least 1 voriconazole plasma level measured during therapy
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Voriconazole plasma levels during routine intravenous and oral therapy
Time frame: trough levels every 4 days after start or dose adjustment of voriconazole
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Vanstraelen, R.Ph. principal investigator
Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Treated With Voriconazole, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voriconazole plasma levels during routine intravenous and oral therapy (time frame: trough levels every 4 days after start or dose adjustment of voriconazole). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.