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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01418846
First Posted: August 17, 2011
Last Update Posted: January 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
  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 ]

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

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01418846     History of Changes
Other Study ID Numbers: ML7401
First Submitted: August 16, 2011
First Posted: August 17, 2011
Last Update Posted: January 13, 2015
Last Verified: February 2013

Keywords provided by Universitaire Ziekenhuizen Leuven:
voriconazole
saliva
pharmacokinetics

Additional relevant MeSH terms:
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors