Anidulafungin During Continuous Venovenous Hemofiltration (CVVHF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00892359
First received: April 30, 2009
Last updated: May 1, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Acute Renal Failure
Infection
Drug: Anidulafungin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Pharmacokinetics of Anidulafungin During Continuous Venovenous Hemofiltration

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Anidulafungin area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2009
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anidulafungin Drug: Anidulafungin
treatment for 3 days, 200 mg intravenously on the first treatment day and 100 mg on the 2 following treatment days each.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892359

Contacts
Contact: Judith M Leitner, M.D. +43140400 ext 4440 judith.leitner@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Judith M Leitner, M.D.    +43140400    judith.leitner@meduniwien.ac.at   
Sub-Investigator: Judith M Leitner, M.D.         
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Florian Thalhammer, M.D., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00892359     History of Changes
Other Study ID Numbers: 1.1 - Leitner
Study First Received: April 30, 2009
Last Updated: May 1, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
pharmacokinetics
renal replacement therapy
hemofiltration
anidulafungin

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014