Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients
Completed
- Conditions
- Internal MedicinePediatricsPneumologyHematology
- Registration Number
- NCT01418846
- Lead Sponsor
- Universitaire Ziekenhuizen KU 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Voriconazole pharmacokinetics in saliva and plasma in different patient populations One day at steady state of voriconazole plasma levels
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
University Hospital Brussels - Cystic Fibrosis Clinic
🇧🇪Brussels, Belgium
Ghent University Hospital - Cystic Fibrosis Clinic
🇧🇪Ghent, East Flanders, Belgium
University Hospitals Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium