Intra-abdominal candidiasis is the most frequent candidiasis infection after candidemia. The studies that have positioned echinocandins as the first therapeutic option in candidiasis have been carried out mainly in patients with candidemia. Peritoneal concentrations of caspofungin, micafungin and anidulafungin are clearly above the MICs of most Candida spp but are below the threshold for selection of resistant mutants, which has been argued by some researchers as a risk for the control of intra-abdominal infections with poor control of the focus and selection of resistant mutants, observed in Candida spp isolates at the peritoneal level in relation to isolates at the blood culture level.
Rezafungin, with its special pharmacokinetics, achieves higher tissue concentrations, including hepato-splenic and other abdominal organs, than the other echinocandins. Experimental studies have confirmed that the concentration of rezafungin at the level of the inflammatory focus in abdominal infections is higher than in the surrounding healthy tissue and higher than those achieved by micafungin. Finally, the biofilm activity of rezafungin is very high, clearly superior to fluconazole and possibly higher than that of other echinocandins.
Patients with suspicion, confirmed or not, of candidiasis peritonitis or intra-abdominal infection by Candida spp. who, after having received information about the design, the purpose of the study, the possible risks that may arise from it and that they can refuse to collaborate at any time, give written consent to participate in the study.
Be over 18 years of age
Understand the purpose of the study and be available to perform the visits and procedures established in the protocol
In women: negative urine pregnancy test performed in the 7 days prior to the start of study treatment in women of childbearing age and if < 2 years have passed after menopause
Patients in whom there is any contraindication for use according to the established in the technical data sheet or known hypersensitivity to rezafungin or who, according to the investigator's criteria, it is not advisable to participate.
Patients who do not present suspicion of intra-abdominal candidiasis infection or who are receiving antifungal treatment for another reason.
Patients receiving another antifungal drug during rezafungin administration.
Single group
Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg
DrugIntravenous administration of a first dose of Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg to study the pharmacokinetic parameters of the drug.
Peack Plasma Concentration (Cmax)
Evaluation of the ratio between Cmax, Cmin and Area Under the Rezafungin Curve in peritoneal fluid in relation to Cmax, Cmin and Area Under the Rezafungin Curve levels in blood.
Minimum Plasma Concentration (Cmin)
Evaluation of the ratio between Cmax, Cmin and Area Under the Rezafungin Curve in peritoneal fluid in relation to Cmax, Cmin and Area Under the Rezafungin Curve levels in blood.
Area Under the Rezafungin Curve levels in blood.
Evaluation of the ratio between Cmax, Cmin and Area Under the Rezafungin Curve in peritoneal fluid in relation to Cmax, Cmin and Area Under the Rezafungin Curve levels in blood.
Death curve analysis
Analysis of peritoneal fluid death curves in the samples per patient obtained
Duration of treatment
Time in days or weeks that the treatment lasts for each patient
Overall mortality
Mortality, related or not to the treatment
Atributable mortality
Mortality related to the treatment
Blood tests
Data obtained from the performance of blood tests
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