Pharmacokinetic Study of Rezafungin in Patients With Suspected Intra-Abdominal Candidiasis

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg

Treatment groups

20 Participants
are divided into 1 treatment group