Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 8:44 PM
Study NCT ID:
NCT00892359
Status:
UNKNOWN
Last Update Posted:
2009-05-04
First Post:
2009-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anidulafungin During Continuous Venovenous Hemofiltration (CVVHF)
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
The Pharmacokinetics of Anidulafungin During Continuous Venovenous Hemofiltration
Status:
UNKNOWN
Status Verified Date:
2009-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: