Candida Sepsis Clinical Trial
Official title:
Pharmacokinetics of Micafungin During Continuous Venovenous Hemofiltration
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.
n/a
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05264571 -
Early Identification of Candida in Intra-abdominal Candidiasis
|