Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients

Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients.

The purpose of this study is to investigate the intra-saliva penetration of voriconazole in different subpopulations. The goal is to develop, optimize and validate an easy, non-invasive and painless procedure for Therapeutic Drud Monitoring of voriconazole that can be used in children, ambulatory patients and in patients in whom blood drawing is difficult.

Study Overview

• Status: Completed
• Conditions: Pediatrics; Hematology; Internal Medicine; Pneumology

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • University Hospital Brussels - Cystic Fibrosis Clinic
  • East Flanders
    • Ghent, East Flanders, Belgium, 9000
      • Ghent University Hospital - Cystic Fibrosis Clinic
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized at the pneumology ward, adult hematology ward and all hospitalized pediatric patients, treated with voriconazole.

Description

Inclusion Criteria:

• patients from the adult hematology ward treated with voriconazole
• pediatric patients treated with voriconazole, age 5-18 years
• patients from the pneumology ward treated with voriconazole

Exclusion Criteria:

• Age under 5 years
• Women who are pregnant or lactating
• Mucositis stage 3 or 4 (WHO)
• Patients which received the following drugs within 14 days before study entry: rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz and barbiturates.
• Patients which received the following drugs within 24hours before study entry: quinidine, ergotamine, sirolimus, saquinavir, amprenavir, nelfinavir, ritonavir and sulphonylureas.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
adult hematology patients
pediatric patients age 5-18years
adult pneumology patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Voriconazole pharmacokinetics in saliva and plasma in different patient populations	One day at steady state of voriconazole plasma levels

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Kim Vanstraelen, R.Ph., Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: August 16, 2011
• First Submitted That Met QC Criteria: August 16, 2011
• First Posted (Estimate): August 17, 2011

Study Record Updates

• Last Update Posted (Estimate): January 13, 2015
• Last Update Submitted That Met QC Criteria: January 12, 2015
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: pharmacokinetics; voriconazole; saliva
• Other Study ID Numbers: ML7401