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

NCT06985758 | Not Yet Recruiting Phase 4

• 1 other identifier: REZAPACQ
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Candidal Peritonitis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Duration of treatment

  8 weeks

• Overall mortality

  8 weeks

• Atributable mortality

  8 weeks

• Blood tests

  8 weeks

• Intra-abdominal cultures

  8 weeks

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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.

Also known as: Rezafungin

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (3)

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Interventions

Rezafungin

Study Officials

• Jesús Fortún Abete, MD

  IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesús Fortún Abete, MD

CONTACT

+34918032153; fortunabete@gmail.com

Pilar Martín Dávila, MD

CONTACT

+34918032153; pmartindav@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 22, 2025
• Study Start: September 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)