invasive candidiasis MedDRA version: 12.0 Level: LLT Classification code 10064954 Term: Invasive candidiasis
Conditions
Interventions
Trade Name: Ecalta
Pharmaceutical Form: Powder and solvent for solution for infusion
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1) allergic to anidulafungin or its excipients 2) contra-indication stated in IB1-brochure 3) neutropenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - Mortality at day 28 due to fungal infection and overall mortality at 28 days - AUC/MIC ratio, time above MIC - Composing a PK model of anidulafungin in critically ill patients ;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. | — |
Countries
Netherlands
Outcome results
None listed