Plasma Protein Binding Characteristics of Voriconazole

NCT01812473 | Completed Results

• 2 other identifiers: ML89492013-000559-42
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Focus of the Study:Protein Binding Characteristics of Voriconazole.

Keywords

protein binding; voriconazole; pediatrics; hematology; intensive care; albumin; alpha-1-acid-glycoprotein

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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

Interventions

Blood sampling OTHER

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

Patients admitted to the Intensive Care Unit

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the intensive care unit

You may qualify if:

• treated with voriconazole

You may not qualify if:

• None

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and serum samples are obtained to determine the albumin and alpha-1-acid-glycoprotein level.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

Relatively small data set. Only adult ICU patients. No data are available for plasma albumin concentrations above 40 g/liter.

Results Point of Contact

• Title: Kim Vanstraelen, PharmD
• Organization: Universitaire Ziekenhuizen Leuven

kim_vanstraelen@hotmail.com

0032 16 342339

Study Officials

• Kim Vanstraelen, PharmD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 18, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 24, 2015
• Results First Posted: February 18, 2015

Record last verified: 2013-03

Locations

BE (1)