Determination of voriconazole in Saliva in specific patient populations.

Phase 1

• Conditions: patients suffering from an invasive fungal infection, treated with intravenous or oral voriconazole.; MedDRA version: 20.1Level: LLTClassification code 10042941Term: Systemic fungal infection NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-001396-37-BE
• Lead Sponsor: niversity Hospitals Leuven, Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-06
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified