Anidulafungin During Continuous Venovenous Hemofiltration (CVVHF)

NCT00892359 | Unknown Phase 2

• 1 other identifier: 1.1 - Leitner
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

pharmacokinetics; renal replacement therapy; hemofiltration; anidulafungin

Outcome Measures

Primary Outcomes (1)

• Anidulafungin area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.

  1 year

Study Arms (1)

Anidulafungin

EXPERIMENTAL

Drug: Anidulafungin

Interventions

Anidulafungin DRUG

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

Anidulafungin

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Infections

Interventions

Anidulafungin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Echinocandins; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Judith M Leitner, M.D.

CONTACT

+43140400; judith.leitner@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 4, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2010
• Last Updated: May 4, 2009

Record last verified: 2009-04

Locations

AU (1)