Pharmacokinetic Study of Rezafungin in Patients with Suspected Intra-Abdominal Candidiasis: Peritoneal Diffusion and Candicidal Activity

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

22 Dec 2025 → ongoing

Decision date (initial)

2025-08-13

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

To analyse the following PK parameters: Cmax, Cmin and area under the curve of rezafungin in blood and peritoneal fluid in patients with suspected intra-abdominal candidiasis.
To evaluate the Candicidal activity of peritoneal fluid against two reference strains of Candida albicans and Candida glabrata, using kill curves.

Secondary objectives 2

1. Safety: Laboratory tests and Adverse Reactions. All patients will undergo a weekly safety test for the duration of rezafungin and an end-of-treatment test.
2. Clinical and microbiological response: In patients with intra-abdominal candidiasis peritonitis (see criteria), a secondary analysis of therapeutic efficacy with clinical and microbiological response assessment will be performed at the end of treatment with rezafungin and at the end of follow-up.

Conditions and MedDRA coding

Intra-Abdominal Candidiasis.

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients with confirmed or unconfirmed suspicion of candidal peritonitis or intra-abdominal Candida spp. infection who, after receiving information about the study design, the purpose of the study, the potential risks involved and that they may refuse to participate at any time, give written consent to participate in the study.
2. Be over 18 years of age.
3. Understand the purpose of the study and be available to perform the visits and procedures established in the protocol.
4. In women: negative urine pregnancy test performed within 7 days prior to the start of study treatment in women of childbearing age and if < 2 years have passed since menopause.
5. Patients with signs of peritonitis or intra-abdominal infection who show refractoriness after at least 48 hours of empirical or specific antibiotherapy and in whom candidiasis infection is suspected.
6. Patients with an abdominal or peritoneal drain with a permeable debit that allows peritoneal samples to be obtained through it.

Exclusion criteria 3

1. Patients in whom there is a contraindication for use in accordance with the terms of the technical data sheet or known hypersensitivity to rezafungin or whose participation is not advisable in the opinion of the investigator.
2. Patients who do not present suspicion of intra-abdominal candidiasis or who are receiving antifungal treatment for another reason.
3. Patients receiving another antifungal drug during rezafungin administration.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Peritoneal diffusion rate of Rezafungin. Ratio of Cmax, Cmin and Area Under the Rezafungin Curve in peritoneal fluid to Cmax, Cmin and Area Under the Rezafungin Curve in blood.
2. Analysis of peritoneal fluid death curves in the samples per patient obtained according to the previous point.

Secondary endpoints 4

1. Duration of treatment.
2. Overall mortality
3. Attributable mortality.
4. Clinical and microbiological cure.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Sponsor organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Address

Carretera Del Colmenar Viejo Km 9100, Por El Pardo Por El Pardo

City

Madrid

Postcode

28034

Country

Spain

Scientific contact point

Organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Contact name

Itziar de Pablo López de Abechuco

Public contact point

Organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Contact name

Itziar de Pablo López de Abechuco

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications