Study of the bioavailability of voriconazole in intensive care patients
- Conditions
- Suspected or prophylaxis of invasive aspergillosis.Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-001222-15-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Blood sampling by central venous catheter or peripheral cannula not possible;
Concomitantly using a strong inhibitor or inducer of CYP P450.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br>;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 Outcome Measures
Name Time Method 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.