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

This study is currently recruiting participants.
Verified February 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01418846
First received: August 16, 2011
Last updated: March 1, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
10 adult hematology patients
10 pediatric patients age 5-12 years
All hospitalized pediatric patients treated with voriconazole are eligible for this cohort
10 general internal medicine patients
10 pneumology patients
10 pediatric patients age 13-18 years
All hospitalized pediatric patients treated with voriconazole are eligible for this cohort

  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 or general internal medicine, 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 5-12 years
  • pediatric patients treated with voriconazole, age 13-18 years
  • patients from the pneumology ward treated with voriconazole
  • patients from general internal medicine 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418846

Contacts
Contact: Kim Vanstraelen, R.Ph. (+32) (0)16 342339 kim.vanstraelen@uzleuven.be
Contact: Isabel Spriet, Pharm.D. isabel.spriet@uzleuven.be

Locations
Belgium
Ghent University Hospital - Cystic Fibrosis Clinic Recruiting
Ghent, East Flanders, Belgium, 9000
Principal Investigator: Petra Schelstraete, PhD, MD            
University Hospitals Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Principal Investigator: Kim Vanstraelen, R.Ph.            
Sub-Investigator: Isabel Spriet, Pharm.D.            
Sub-Investigator: Ludo Willems, Professor            
University Hospital Brussels - Cystic Fibrosis Clinic Recruiting
Brussels, Belgium, 1090
Principal Investigator: Anne Malfroot, PhD,MD,Prof.            
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: March 1, 2013
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
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013