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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01418846
First received: August 16, 2011
Last updated: January 12, 2015
Last verified: February 2013
  Purpose

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.


Condition
Pneumology
Hematology
Internal Medicine
Pediatrics

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Voriconazole pharmacokinetics in saliva and plasma in different patient populations [ Time Frame: One day at steady state of voriconazole plasma levels ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: October 2012
Study Completion Date: November 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
adult hematology patients
pediatric patients age 5-18years
adult pneumology patients

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418846

Locations
Belgium
Ghent University Hospital - Cystic Fibrosis Clinic
Ghent, East Flanders, Belgium, 9000
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
University Hospital Brussels - Cystic Fibrosis Clinic
Brussels, Belgium, 1090
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Kim Vanstraelen, R.Ph. Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01418846     History of Changes
Other Study ID Numbers: ML7401
Study First Received: August 16, 2011
Last Updated: January 12, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
voriconazole
saliva
pharmacokinetics

Additional relevant MeSH terms:
Voriconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2015