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

Phase IV, Open-label, Single Arm, Multicenter Trial to Evaluate Pharmacokinetic Parameters of Peritoneal Diffusion and Peritoneal Diffusion Activity.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Candidal Peritonitis
• Intervention / Treatment: Drug: Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg

Detailed Description

Intra-abdominal candidiasis is the most common candidal infection after candididaemia. Studies that have positioned echinocandins as the first therapeutic option in candidiasis have been conducted primarily in patients with candidaemia. 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 relative to isolates at the blood culture level.

Rezafungin has the characteristic of having a modified chemical structure that gives it greater stability and a prolonged half-life, allowing the drug to be administered less frequently on a weekly rather than daily basis. This results in greater clearance of candidemia and greater penetration and persistence in tissues compared to other echinocandins, and improves patient adherence to treatment.

The efficacy of Rezafungin has already been evaluated in clinical trials, and has been shown to be equal or superior to that of other echinocandins, and because it has a low incidence of cross-resistance with other antifungals, it is an appropriate choice for resistant fungal infections.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jesús Fortún Abete, MD; Phone Number: +34918032153; Email: fortunabete@gmail.com
• Study Contact Backup: Name: Pilar Martín Dávila, MD; Phone Number: +34918032153; Email: pmartindav@gmail.com

Study Locations

• Spain
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Hospital Clinico Universitario de Valencia
      • Contact: Gerardo Aguilar Aguilar, MD; Phone Number: +34961854648; Email: gerardo.aguilar@uv.es
  • Comunidad de Madrid
    • Madrid, Comunidad de Madrid, Spain, 28034
      • Hospital Universitario Ramon y Cajal
      • Contact: Jesús Fortún Abete, MD; Phone Number: +34918032153; Email: fortunabete@gmail.com
      • Contact: Pilar Martín Dávila, MD; Phone Number: +34918032153; Email: pmartindav@gmail.com
    • Madrid, Comunidad de Madrid, Spain, 28046
      • Hospital Universitario La Paz
      • Contact: Nuria Pérez Chulia, MD; Phone Number: +34917277273; Email: nurial.perez@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 with signs of peritonitis or intra-abdominal infection showing refractoriness after at least 48 hours of empirical or specific antibiotherapy and in whom candidiasis infection is suspected.
• Patients with abdominal or peritoneal drainage with permeable debit that allows obtaining peritoneal samples through it.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg; Intravenous administration of a first dose of Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg to study the pharmacokinetic parameters of the drug.	Drug: Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg; Intravenous administration of a first dose of Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg to study the pharmacokinetic parameters of the drug.; Other Names: Rezafungin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days
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.	7 days
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.	7 days
Death curve analysis	Analysis of peritoneal fluid death curves in the samples per patient obtained	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of treatment	Time in days or weeks that the treatment lasts for each patient	8 weeks
Overall mortality	Mortality, related or not to the treatment	8 weeks
Atributable mortality	Mortality related to the treatment	8 weeks
Blood tests	Data obtained from the performance of blood tests	8 weeks
Intra-abdominal cultures	Data obtained from intra-abdominal cultures	8 weeks
Radiology tests	Data obtained from radiology tests	8 weeks
Analytical tests	Data obtained from analytical tests	8 weeks

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Investigators: Principal Investigator: Jesús Fortún Abete, MD, IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: May 21, 2025
• First Posted (Actual): May 22, 2025

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Digestive System Diseases; Peritoneal Diseases; Intraabdominal Infections; Peritonitis; Anti-Infective Agents; Antifungal Agents; Rezafungin
• Other Study ID Numbers: REZAPACQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No