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

Pediatrics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418846
• Other study ID #: ML7401
• 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

• Hematology
• Internal Medicine
• Pediatrics
• Pneumology

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