Pharmacokinetics of anidulafungin in critically ill patients with invasive candidiasis
Phase 4
Completed
- Conditions
- invasive candidiasis10017528invasive fungal infection
- Registration Number
- NL-OMON32922
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
treatment with anidulafungin
at least 18 years of age
invasive canidiasis
admitted to an intensive care unit
Exclusion Criteria
allergic to anidulafungin or its excipients
contra-indication stated in IB1-brochure
neutropenia
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the correlation between pharmacokinetic parameters and<br /><br>disease severity scores or a single clinical parameter. Pharmacokinetic<br /><br>parameters will be calculated out of anidulafungin levels and relevant patient<br /><br>data (i.e. bodyweight, renal function, etc) using KINFIT (MWPharm 3.60;<br /><br>Mediware, The Netherlands). A Spearman correlation coefficient will be<br /><br>calculated to assess correlation as we expect that the results will be not<br /><br>normally distributed. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1) Time (in days) to culture conversion<br /><br>2) Response to treatment at day 28<br /><br>3) Mortality at day 28 due to fungal infection and overall mortality at 28 days<br /><br>4) AUC/MIC ratio, time above MIC<br /><br>5) Composing a pharmacokinetic model of anidulafungin in critically ill<br /><br>patients. </p><br>