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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT01418846
Collaborator
(none)
11
Enrollment
3
Locations
25
Duration (Months)
3.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Oct 1, 2012
    Actual Primary Completion Date :
    Jun 1, 2014
    Actual Study Completion Date :
    Nov 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    adult hematology patients
    pediatric patients age 5-18years
    adult pneumology patients

    Outcome Measures

    Primary Outcome Measures

    1. Voriconazole pharmacokinetics in saliva and plasma in different patient populations [One day at steady state of voriconazole plasma levels]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Ghent University Hospital - Cystic Fibrosis Clinic Ghent East Flanders Belgium 9000
    2 University Hospitals Leuven Leuven Vlaams-Brabant Belgium 3000
    3 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT01418846
    Other Study ID Numbers:
    • ML7401
    First Posted:
    Aug 17, 2011
    Last Update Posted:
    Jan 13, 2015
    Last Verified:
    Feb 1, 2013
    Keywords provided by Universitaire Ziekenhuizen Leuven
    voriconazole
    saliva
    pharmacokinetics

    Study Results

    No Results Posted as of Jan 13, 2015