Suspected or prophylaxis of invasive aspergillosis.
Conditions
Interventions
Trade Name: Vfend
Pharmaceutical Form: Powder for solution for infusion
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged = 18 yrs; Treatmen with VCZ; Admission to an ICU; Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 13 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: Blood sampling by central venous catheter or peripheral cannula not possible; Concomitantly using a strong inhibitor or inducer of CYP P450.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is determining the bioavailability of voriconazole in ICU patients. Bioavailability will be calculated by determining the AUC of an intravenous and the AUC of an oral dose of voriconazole. ;Secondary Objective: To get an indication of the influence of disease severity, determined with the APACHE IV score, and the degree of inflammation, determined with CRP, on the bioavailability of voriconazole.;Primary end point(s): Bioavailability < 80%, calculated using the area under the concentration time curve (AUC) of an intravenous an oral dose of voriconazole, is considered to be an important clinical difference. ;Timepoint(s) of evaluation of this end point: 24 hours after administration of an intravenous and oral dose of voriconazole, wherein the patient received at least four doses of voriconazole. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 24 hours after administration of an intravenous and oral dose of voriconazole, wherein the patient received at least four doses of voriconazole. ;Secondary end point(s): To get an indication of the influence of disease severity, determined with the APACHE IV score, and the degree of inflammation, determined with CRP, on the bioavailability of voriconazole. | — |
Countries
Netherlands
Contacts
Public ContactClinical Pharmacy and Pharmacology
University Medical Center Groningen
Outcome results
None listed