Anidulafungin During Continuous Venovenous Hemofiltration (CVVHF)

NCT ID: NCT00892359

Last Updated: 2009-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30

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.

Conditions

Acute Renal Failure; Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anidulafungin

Group Type: EXPERIMENTAL

Anidulafungin

Intervention Type: DRUG

treatment for 3 days, 200 mg intravenously on the first treatment day and 100 mg on the 2 following treatment days each.

Interventions

Anidulafungin

treatment for 3 days, 200 mg intravenously on the first treatment day and 100 mg on the 2 following treatment days each.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Judith M Leitner, M.D.

Role: CONTACT

judith.leitner@meduniwien.ac.at

+43140400 ext. 4440

Facility Contacts

Judith M Leitner, M.D.

Role: primary

judith.leitner@meduniwien.ac.at

+43140400

Other Identifiers

1.1 - Leitner

Identifier Type: -

Identifier Source: org_study_id