Determination of voriconazole in Saliva in specific patient populations.

Determination of voriconazole in saliva - Validation in specifif subsets of patients. - Determination of voriconazole in saliva

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001396-37-BE

Enrollment

Registered

2021-04-06

Start date

2012-03-29

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

patients suffering from an invasive fungal infection, treated with intravenous or oral voriconazole. MedDRA version: 20.1 Level: LLT Classification code 10042941 Term: Systemic fungal infection NOS System Organ Class: 100000004862

Interventions

Trade Name: Vfend Pharmaceutical Form: Tablet INN or Proposed INN: VORICONAZOLE CAS Number: 137234-62-9 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 200- Trade

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients suffering from an invasive fungal infection, therefore treated with intravenous or oral voriconazole, admitted to the adult pneumology or hematology or internal medicine ward. Pediatric patients between 5-18 years suffering from an invasive fungal infection, treated with intravenous or oral voriconazole. Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: less than 5 years of age, women who are pregnant/lactating, patients suffering from severe mucositis (WHO grade 3 or 4), patients treated with drugs interacting with voriconazole (rifampicine, rifabutin, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz, barbiturates, quinidine, ergotamine, sirolimus, saquinavir, amprenavir, nelfinavir, delvardine, ritonavir, sulphonylureas.

Design outcomes

Primary

Measure	Time frame
Main Objective: Developing en validating a non-invasive method for therapeutic drug monitoring of the antifungal drug voriconazole, using saliva samples.;Secondary Objective: Investigation of the pharmacokinetics of voriconazole in saliva in different patient populations.;Primary end point(s): Pharmacokinetics of voriconazole in saliva.;Timepoint(s) of evaluation of this end point: Samples will be taken during one day per patient, at least 4 days after start of voriconazole therapy to insure steady state levels of voriconazole.	—

Measure

Time frame

Main Objective: Developing en validating a non-invasive method for therapeutic drug monitoring of the antifungal drug voriconazole, using saliva samples.;Secondary Objective: Investigation of the pharmacokinetics of voriconazole in saliva in different patient populations.;Primary end point(s): Pharmacokinetics of voriconazole in saliva.;Timepoint(s) of evaluation of this end point: Samples will be taken during one day per patient, at least 4 days after start of voriconazole therapy to insure steady state levels of voriconazole.

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactSponsor - Head Investigator

University Hospitals Leuven

kim.vanstraelen@uzleuven.be003216342339

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026