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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Hematology; Pneumology; Internal Medicine; Pediatrics

Study type: Observational

Funder types: Other

Identifiers

NCT01418846

ML7401

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

11 participants in 3 patient groups

adult hematology patients

pediatric patients age 5-18years

adult pneumology patients