Anidulafungin During Continuous Venovenous Hemofiltration (CVVHF)

Infection Clinical Trial

Official title:

The Pharmacokinetics of Anidulafungin During Continuous Venovenous Hemofiltration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00892359
• Other study ID #: 1.1 - Leitner
• Status: Recruiting
• Phase: Phase 2
• First received: April 30, 2009
• Last updated: May 1, 2009
• Start date: April 2009

Study information

• Verified date: April 2009
• Source: Medical University of Vienna
• Contact: Judith M Leitner, M.D.
• Phone: +43140400
• Email: judith.leitner[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Infection

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anidulafungin area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.		1 year	No