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| Sponsored by: |
Medical University of Vienna |
|---|---|
| Information provided by: | Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00892359 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | The Pharmacokinetics of Anidulafungin During Continuous Venovenous Hemofiltration |
| 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 |
|---|---|
| Anidulafungin: Experimental |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Judith M Leitner, M.D. | +43140400 ext 4440 | judith.leitner@meduniwien.ac.at |
| 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. | |
More Information
| Responsible Party: | Medical University of Vienna ( Florian Thalhammer, M.D. ) |
| Study ID Numbers: | 1.1 - Leitner |
| Study First Received: | April 30, 2009 |
| Last Updated: | May 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00892359 History of Changes |
| Health Authority: | Austria: Agency for Health and Food Safety |
|
pharmacokinetics renal replacement therapy hemofiltration anidulafungin |
|
Renal Insufficiency Echinocandins Clotrimazole Miconazole Tioconazole Anidulafungin Anti-Bacterial Agents |
Urologic Diseases Antifungal Agents Kidney Failure, Acute Kidney Diseases Renal Insufficiency, Acute Kidney Failure |
|
Anti-Infective Agents Renal Insufficiency Echinocandins Infection Pharmacologic Actions Anidulafungin Urologic Diseases |
Antifungal Agents Therapeutic Uses Antibiotics, Antifungal Kidney Failure, Acute Kidney Diseases Renal Insufficiency, Acute Kidney Failure |
