Pediatrics Clinical Trial
Official title:
Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients.
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | November 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Brussels - Cystic Fibrosis Clinic | Brussels | |
Belgium | Ghent University Hospital - Cystic Fibrosis Clinic | Ghent | East Flanders |
Belgium | University Hospitals Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Voriconazole pharmacokinetics in saliva and plasma in different patient populations | One day at steady state of voriconazole plasma levels | No |
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---|---|---|---|
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