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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumology Hematology Internal Medicine Pediatrics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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adult hematology patients

No interventions assigned to this group

pediatric patients age 5-18years

No interventions assigned to this group

adult pneumology patients

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No