Pharmacokinetics of Micafungin During Continuous Venovenous Hemofiltration

Candida Sepsis Clinical Trial

— Mica-HDF  

Official title:

Pharmacokinetics of Micafungin During Continuous Venovenous Hemofiltration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651038
• Other study ID #: Mica_HDF
• Status: Completed
• Phase: Phase 4
• First received: July 17, 2015
• Last updated: January 7, 2016
• Start date: May 2012
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 79 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candida Sepsis

Intervention

Drug:
• Micafungin
Measurement of PK

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemofiltration clearance of Micafungin	Haemofiltration clearance in ml/min measured by micafungin concentration gradient between hemodialyzer inlet and outlet port.	49 hours	No