- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00892359
Anidulafungin During Continuous Venovenous Hemofiltration (CVVHF)
The Pharmacokinetics of Anidulafungin During Continuous Venovenous Hemofiltration
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Judith M Leitner, M.D.
- Phone Number: 4440 +43140400
- Email: judith.leitner@meduniwien.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Medical University of Vienna
-
Contact:
- Judith M Leitner, M.D.
- Phone Number: +43140400
- Email: judith.leitner@meduniwien.ac.at
-
Sub-Investigator:
- Judith M Leitner, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anidulafungin
|
treatment for 3 days, 200 mg intravenously on the first treatment day and 100 mg on the 2 following treatment days each.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anidulafungin area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.1 - Leitner
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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