Status:
COMPLETED
Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Pneumology
Hematology
Eligibility:
All Genders
5+ years
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01418846
Start Date
October 1 2012
End Date
November 1 2014
Last Update
January 13 2015
Active Locations (3)
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1
University Hospital Brussels - Cystic Fibrosis Clinic
Brussels, Brussels Capital, Belgium, 1090
2
Ghent University Hospital - Cystic Fibrosis Clinic
Ghent, East Flanders, Belgium, 9000
3
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000