Skip to content

Pharmacokinetics of Micafungin During Continuous Venovenous Hemofiltration

Pharmacokinetics of Micafungin During Continuous Venovenous Hemofiltration

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02651038
Acronym
Mica-HDF
Enrollment
10
Registered
2016-01-08
Start date
2012-05-31
Completion date
2016-01-31
Last updated
2016-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candida Sepsis

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.

Interventions

DRUGMicafungin

Measurement of PK

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Haemofiltration clearance of Micafungin49 hoursHaemofiltration clearance in ml/min measured by micafungin concentration gradient between hemodialyzer inlet and outlet port.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026