Focus of the Study:Protein Binding Characteristics of Voriconazole.NCT01812473

Plasma Protein Binding Characteristics of Voriconazole

An observational study of Focus of the Study:Protein Binding Characteristics of Voriconazole., run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the influence of hypoalbuminemia on the protein binding characteristics of the antifungal drug voriconazole in ICU patients. Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Focus of the Study:Protein Binding Characteristics of Voriconazole.
What is being tested?: Blood sampling
How many people: 35 participants
Where: 1 siteBelgium
Study dates: Feb 2013to Dec 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients admitted to the intensive care unit

Who may be able to join

treated with voriconazole

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Belgium1 site

University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

About this study

Official title: Impact of Hypoalbuminemia on Voriconazole Pharmacokinetics in Critically Ill Adult Patients.

The purpose of this study is to investigate the influence of hypoalbuminemia on the protein binding characteristics of the antifungal drug voriconazole in ICU patients.

Conditions: Focus of the Study:Protein Binding Characteristics of Voriconazole.
Being tested: Blood sampling
Keywords: protein binding, voriconazole, pediatrics, hematology, intensive care, albumin, alpha-1-acid-glycoprotein

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood samplingOther
During the treatment of voriconazole, at steady plasma concentrations of voriconazole, one plasma sample and one serum sample are taken.

Study groups in NCT01812473
Study group	Role	What they receive
Patients admitted to the Intensive Care Unit		All patients admitted to the Intensive Care Unit, treated with voriconazole are eligible for the study. Receives: Other: Blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations.
At steady state plasma concentrations of voriconazole, a plasma sample is taken to determine the overall protein binding of voriconazole. Equilibrium dialysis is used, followed by liquid chromatography-mass spectrometry.
Measured: At steady state plasma concentration of voriconazole (after day 4 of therapy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Dec 2013

First posted18 Mar 2013 (estimated)
Study startFeb 2013
Primary completionJun 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Focus of the Study:Protein Binding Characteristics of Voriconazole.Studies 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: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01812473
Sponsor's protocol ID: ML8949
Other IDs: 2013-000559-42
Status last verified: Mar 2013
First submitted: 1 Mar 2013
Last updated: 24 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Hypoalbuminemia on Voriconazole Pharmacokinetics in Critically Ill Adult Patients.
ClinicalTrials.gov ID: NCT01812473
Acronym / sponsor ID: ML8949
Conditions: Focus of the Study:Protein Binding Characteristics of Voriconazole.
Keywords: protein binding, voriconazole, pediatrics, hematology, intensive care, albumin, alpha-1-acid-glycoprotein
Study type: Observational
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
Study start: Feb 2013
Primary completion: Jun 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 18 Mar 2013 (estimated)
Results: Posted 18 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to investigate the influence of hypoalbuminemia on the protein binding characteristics of the antifungal drug voriconazole in ICU patients.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients admitted to the Intensive Care Unit	–	Other: Blood samplingAll patients admitted to the Intensive Care Unit, treated with voriconazole are eligible for the study.

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients admitted to the intensive care unit

Key inclusion criteria (1 listed)

treated with voriconazole

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.

Interventions

Intervention	Type	Arms
Blood samplingDuring the treatment of voriconazole, at steady plasma concentrations of voriconazole, one plasma sample and one serum sample are taken.	Other	Patients admitted to the Intensive Care Unit

Primary outcome

Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations.
Time frame: At steady state plasma concentration of voriconazole (after day 4 of therapy)
At steady state plasma concentrations of voriconazole, a plasma sample is taken to determine the overall protein binding of voriconazole. Equilibrium dialysis is used, followed by liquid chromatography-mass spectrometry.

Results and safety

Results posted to the registry on 18 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Admitted to the ICU Not Treated With Voriconazole	22	22
Patients Admitted to the ICU Treated With Voriconazole	13	13

Primary outcome: Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations.

Time frame: At steady state plasma concentration of voriconazole (after day 4 of therapy). Median (Inter-Quartile Range). Unit: % of plasma protein binding

Measure	Patients Admitted Tot the ICU Not Treated With Voriconazole n = 22	Patients Admitted to the ICU Treated With Voriconazole n = 13
Value	49.1 (42.6 to 52.3)	49.6 (42.5 to 52.5)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Admitted Tot the ICU Not Treated With Voriconazole	0 of 22 (0%)	0 of 22 (0%)	Not reported
Patients Admitted to the ICU Treated With Voriconazole	0 of 13 (0%)	0 of 13 (0%)	Not reported

Limitations and caveats (from the sponsor): Relatively small data set. Only adult ICU patients. No data are available for plasma albumin concentrations above 40 g/liter.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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, PharmD principal investigator

Universitaire Ziekenhuizen KU Leuven

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 Focus of the Study:Protein Binding Characteristics of 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 1 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 24 Mar 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?

Yes. Results are posted in the registry (first posted 18 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations. (time frame: At steady state plasma concentration of voriconazole (after day 4 of therapy)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01812473.

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 24 Mar 2015.