Infection Clinical Trial
Official title:
The Pharmacokinetics of Anidulafungin During Continuous Venovenous Hemofiltration
The purpose of this trial is to study the pharmacokinetics of anidulafungin during
continuous venovenous hemofiltration.
Background: Anidulafungin is a cyclic lipopeptide antifungal agent of the echinocandin
class. Members of this class of antifungal agents are known to inhibit the synthesis of
glucan polymers in fungal cell walls. The spectrum of activity of anidulafungin includes
Candida (all species, including strains resistant to fluconazole), Aspergillus, and
Pneumocystis.
In intensive care patients continuous venovenous haemodiafiltration (CVVHF) is a
well-established extracorporal renal replacement therapy with a high clearance rate.
Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVHF
are rare. No data about anidulafungin in CVVHF are available although intensive care
patients are perfect candidates for anidulafungin treatment due to their high risk profile
for systemic fungal infections.
Study objective: The study is conducted to investigate the pharmacokinetics of anidulafungin
during CVVHF in critically ill patients.
Study design: open, 1 arm
Study population: 10 critically ill adult patients administered to the ICU with acute renal
failure and suspected or proven fungal infection.
Treatment/Dosage/Route: On the first day 200 mg of anidulafungin will be administered
intravenously over 3 hours (loading dose). The following days 100 mg of anidulafungin will
be administered intravenously over 1.5 hours.
Main outcome variables: The following pharmacokinetic parameters will be determined: area
under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination
fraction.
Methods: High pressure liquid chromatography (HPLC) will be used to determine anidulafungin
concentrations.
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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