Protein binding characteristics of voriconazole in blood in different groups of patients

Phase 1

• Conditions: Patients suffering from an invasive fungal infection, treated with intravenous or oral voriconazole.; MedDRA version: 14.1Level: LLTClassification code 10042941Term: Systemic fungal infection NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-000559-42-BE
• Lead Sponsor: niversity Hospitals Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-05
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Adults suffering from an invasive fungal infection, therefore treated with intravenous or oral voriconazole, admitted to the adult hematology ward or intensive care unit.
Pediatric patients between 2 and 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: 10
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

Women who are pregnant/lactating, 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

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigation of the protein binding characteristics of voriconazole in human plasma.;Secondary Objective: Comparison of the protein binding characteristics of voriconazole in plasma in different patient populations.;Primary end point(s): Protein binding characteristics of voriconazole in human plasma: percentage of binding, influence of albumine or alfa-1-acid glycoprotein levels in plasma, influence of bilirubin levels and other confounding factors.;Timepoint(s) of evaluation of this end point: 1 plasma sample and 1 serum sample will be taken during one day per patient, at least 4 days after start of voriconazole therapy to insure steady state plasmalevels of voriconazole.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Influence of age, weight, pathology, laboratory parameters of different patients on the protein binding characteristics of voriconazole.;Timepoint(s) of evaluation of this end point: 1 plasma sample and 1 serum sample will be taken during one day per patient, at least 4 days after start of voriconazole therapy to insure steady state plasmalevels of voriconazole.