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Plasma Protein Binding Characteristics of Voriconazole

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ClinicalTrials.gov Identifier: NCT01812473
Recruitment Status : Completed
First Posted : March 18, 2013
Results First Posted : February 18, 2015
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Focus of the Study:Protein Binding Characteristics of Voriconazole. Other: Blood sampling

Study Design
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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Hypoalbuminemia on Voriconazole Pharmacokinetics in Critically Ill Adult Patients.
Study Start Date : February 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients admitted to the Intensive Care Unit
All patients admitted to the Intensive Care Unit, treated with voriconazole are eligible for the study.
 Other: Blood sampling
During the treatment of voriconazole, at steady plasma concentrations of voriconazole, one plasma sample and one serum sample are taken.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Plasma and serum samples are obtained to determine the albumin and alpha-1-acid-glycoprotein level.

Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to the intensive care unit
Criteria

Inclusion Criteria:

  • treated with voriconazole

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812473


Locations
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Belgium
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Kim Vanstraelen, PharmD Universitaire Ziekenhuizen Leuven
More Information
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01812473    
Other Study ID Numbers: ML8949
2013-000559-42 ( EudraCT Number )
First Posted: March 18, 2013    Key Record Dates
Results First Posted: February 18, 2015
Last Update Posted: March 24, 2015
Last Verified: March 2013
Keywords provided by Universitaire Ziekenhuizen Leuven:
protein binding
voriconazole
pediatrics
hematology
 intensive care
albumin
alpha-1-acid-glycoprotein