Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01418846
Enrollment
11
Registered
2011-08-17
Start date
2012-10-31
Completion date
2014-11-30
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematology, Internal Medicine, Pediatrics, Pneumology

Keywords

voriconazole, saliva, pharmacokinetics

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.

Interventions

None listed

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Voriconazole pharmacokinetics in saliva and plasma in different patient populationsOne day at steady state of voriconazole plasma levels

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026