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

Plasma protein binding characteristics of voriconazole in specific subsets of patients - Protein binding characteristics of voriconazole

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000559-42-BE

Enrollment

Registered

2013-02-05

Start date

2013-03-01

Completion date

Unknown

Last updated

2023-08-21

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: 14.1 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: 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

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).

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Belgium

Contacts

Public ContactKim Vanstraelen

University Hospitals Leuven

kim.vanstraelen@uzleuven.be003216342339

Outcome results

None listed

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