Bioavailability of voriconazole in critically ill patients
Phase 4
Withdrawn
- Conditions
- Suspected or prophylaxis of invasive aspergillosissuspected or prophylaxis of invasive fungal infection.10017528
- Registration Number
- NL-OMON40908
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 13
Inclusion Criteria
Aged * 18 yrs;
Treatment with voriconazole;
Admission to an ICU;
Written informed consent.
Exclusion Criteria
Blood sampling by central venous catheter or peripheral cannula not possible;
Concomitantly using a strong inhibitor or inducer of cytochrome P450.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is determining the bioavailability of voriconazole in ICU<br /><br>patients. Bioavailability will be calculated by determining the AUC of an<br /><br>intravenous and the AUC of an oral dose of voriconazole. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To get an indication of the influence of disease severity, determined with the<br /><br>APACHE IV score, and the degree of inflammation, determined with CRP, on the<br /><br>bioavailability of voriconazole.</p><br>