Plasma Protein Binding Characteristics of Voriconazole

Focus of the Study:Protein Binding Characteristics of Voriconazole. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812473
• Other study ID #: ML8949
• Secondary ID: 2013-000559-42
• Status: Completed
• Phase: N/A
• First received: March 1, 2013
• Last updated: March 3, 2015
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2013
• 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 purpose of this study is to investigate the influence of hypoalbuminemia on the protein binding characteristics of the antifungal drug voriconazole in ICU patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• treated with voriconazole

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• Blood sampling
During the treatment of voriconazole, at steady plasma concentrations of voriconazole, one plasma sample and one serum sample are taken.

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	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.	At steady state plasma concentration of voriconazole (after day 4 of therapy)	No