Pharmacokinetics of critically ill patients with invasive candidiasis - Pharmacokinetics of anidulafungi
- Conditions
- MedDRA version: 12.0Level: LLTClassification code 10064954Term: Invasive candidiasisinvasive candidiasis
- Registration Number
- EUCTR2009-016386-28-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
1) treatment with anidulafungin
2) are at least 18 years of age
3) invasive candidiasis
4) admitted to an intensive care unit
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1) allergic to anidulafungin or its excipients
2) contra-indication stated in IB1-brochure
3) neutropenia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: -To investigate the correlation of pharmacokinetic parameters with markers for disease severity – either disease severity scores (i.e. APACHE, SAPS, SOFA, etc.) or clinical parameters, alone or in combination (i.e. CRP, albumin, PCT, etc.);Secondary Objective: -Time to culture conversion<br>-Mortality at day 28 due to fungal infection and overall mortality at 28 days <br>-AUC/MIC ratio, time above MIC<br>-Composing a PK model of anidulafungin in critically ill patients<br>;Primary end point(s): The primary endpoint is the correlation between pharmacokinetic parameters and disease severity scores or a single clinical parameter. Pharmacokinetic parameters will be calculated out of anidulafungin serum concentration levels using KINFIT (MWPharm 3.60; Mediware, The Netherlands). A Spearman correlation coefficient will be calculated to assess correlation as we expect that the results will be not normally distributed.
- Secondary Outcome Measures
Name Time Method