Pharmacokinetics of Micafungin During Continuous Venovenous Hemofiltration (Mica-HDF)

January 7, 2016 updated by: Florian Thalhammer, Medical University of Vienna

Micafungin 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 micafungin includes Candida (all species, including strains resistant to fluconazole), Aspergillus, and Pneumocystis.

In intensive care patients continuous venovenous haemodiafiltration (CVVHDF) is a well-established extracorporal renal replacement therapy with a high clearance rate.

Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVHDF are rare. Elimination of any given drug by renal replacement therapy is determined by several major factors which are membrane specific, due to physico-chemical properties of the drug and characteristics of the renal replacement technique used.

Ten intensive-care patients with acute renal failure and suspected or proven candida infection are included into the study.

100 mg Micafungin will be infused over a period of sixty minutes via a central venous catheter, different from the venous catheter used for CVVHDF. Blood samples will be drawn on days 1 and 2 from the arterial and venous line of the extracorporeal circuit at 0, 2, 4, 6, 8 and 24h after starting the infusion. Plasma and ultrafiltration samples, collected from the outlet of the ultrafiltrate compartment of the hemofilter, will be taken at corresponding times.

The following pharmacokinetic parameters will be determined: area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1190
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 19 to 70 years
  • Suspected or proven candida infection requiring parenteral antifungal therapy.
  • Continuous venovenous hemo(dia)filtration or Cica HD 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
  • Known epilepsy
  • Known pregnancy
  • Known liver failure
  • Soor oesophagitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Micafungin
Micafungin is administered per clinical need and the pharmacokinetic parameters are analyzed
Drug: Micafungin
Measurement of PK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemofiltration clearance of Micafungin
Time Frame: 49 hours
Haemofiltration clearance in ml/min measured by micafungin concentration gradient between hemodialyzer inlet and outlet port.
49 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Florian Thalhammer, Prof. Dr., Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mica_HDF

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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