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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01418846
Other study ID # ML7401
Secondary ID
Status Completed
Phase N/A
First received August 16, 2011
Last updated January 12, 2015
Start date October 2012
Est. completion date November 2014

Study information

Verified date February 2013
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

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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