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

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. Identifier: NCT01418846
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : January 13, 2015
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
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 or disease
Pneumology Hematology Internal Medicine Pediatrics

Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients.
Study Start Date : October 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

adult hematology patients
pediatric patients age 5-18years
adult pneumology patients

Primary Outcome Measures :
  1. Voriconazole pharmacokinetics in saliva and plasma in different patient populations [ Time Frame: One day at steady state of voriconazole plasma levels ]

Information from the National Library of Medicine

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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.

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.

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 identifier (NCT number): NCT01418846

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
Principal Investigator: Kim Vanstraelen, R.Ph. Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy

Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01418846     History of Changes
Other Study ID Numbers: ML7401
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: February 2013

Keywords provided by Universitaire Ziekenhuizen Leuven:

Additional relevant MeSH terms:
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