Anidulafungin During Continuous Venovenous Hemofiltration (CVVHF)

Phase 2

• Conditions: Acute Renal Failure; Infection
• Interventions: Drug: Anidulafungin

• Registration Number: NCT00892359
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-04
• Study Start: 2009-04
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-05-01
• Last Update Submitted: 2009-05-01
• Study First Posted: 2009-05-04
• Last Update Posted: 2009-05-04
• Primary Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age 19 to 70 years
• Suspected or proven infection requiring parenteral antifungal therapy.
• Continuous venovenous hemofiltration because of an acute renal failure.

Exclusion Criteria

• Known history of hypersensitivity to echinocandins.
• An expected survival of less than three days.
• Known alcohol dependency, epilepsy, pregnancy or liver failure.
• Neutropenic patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anidulafungin	Anidulafungin	-

Primary Outcome Measures

Name	Time	Method
Anidulafungin area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.	1 year

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria