Mica-HDF: Pharmacokinetics of Micafungin During Continuous Venovenous Hemofiltration

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT02651038

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Candida Sepsis	Drug: Micafungin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pharmacokinetics of Micafungin During Continuous Venovenous Hemofiltration

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Micafungin

Micafungin is administered per clinical need and the pharmacokinetic parameters are analyzed

Drug: Micafungin

Measurement of PK

Outcome Measures

Primary Outcome Measures

Haemofiltration clearance of Micafungin [49 hours]
Haemofiltration clearance in ml/min measured by micafungin concentration gradient between hemodialyzer inlet and outlet port.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1190

Sponsors and Collaborators

Medical University of Vienna

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Florian Thalhammer, Prof. Dr., Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT02651038

Other Study ID Numbers:

Mica_HDF

First Posted:

Jan 8, 2016

Last Update Posted:

Jan 8, 2016

Last Verified:

Jan 1, 2016

Additional relevant MeSH terms:

Micafungin

Study Results

No Results Posted as of Jan 8, 2016