Intra-Abdominal InfectionREAREZNCT07093203
Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis
An observational study of Intra-Abdominal Infection and Candida, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
ntra-abdominal candidiasis is a serious infection common in critically ill patients, often leading to high mortality if not treated quickly. Standard antifungal treatments may be less effective due to growing resistance and poor drug penetration into the abdominal cavity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-Abdominal Infection, Candida, Abdominal Surgery Patients
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2025to 24 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective PK study of critically ill adult patients with proven or suspected intra-abdominal candidiasis who are admitted to the surgical ICU at the university hospital of Nancy (France). Adult critically ill patients with suspected intra-abdominal candidiasis requiring abdominal surgery and administration of rezafungin as first-line empirical antifungal treatment just before the abdominal surgery, abdominal drain for at least 2 days after the surgery. Intra-abdominal candidiasis is defined following the 2024 consensus of FUNDICU
Who may be able to join
- age > 18 years
- with a suspected intra-abdominal candidiasis requiring abdominal surgery
- and receiving the administration of rezafungin as first-line empirical antifungal treatment just before or within 1 hour the abdominal surgery
- and having abdominal drain for at least 2 days after the surgery
Who cannot join
- death expected within 24h
- decline to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic of Rezafungin in the Plasma and the Peritoneal Fluid of Critically Ill Patients With Intra-abdominal Candidiasis Requiring Abdominal Surgery
ntra-abdominal candidiasis is a serious infection common in critically ill patients, often leading to high mortality if not treated quickly. Standard antifungal treatments may be less effective due to growing resistance and poor drug penetration into the abdominal cavity. In critically ill patients, drug levels can vary widely due to factors like surgery, inflammation, fluid resuscitation, or extracorporeal support, increasing the risk of underdosing. Rezafungin is a new antifungal agent with a long half-life and broad activity against Candida species, offering potential advantages in this setting. However, there is currently no data on its concentration or effectiveness in the peritoneal fluid of patients with intra-abdominal sepsis. Its long half-life, coupled with repeated pharmacokinetic variations in critical care settings and the risk of insufficient concentrations, may hinder its use in this population.
- Conditions
- Intra-Abdominal Infection, Candida, Abdominal Surgery Patients, Critically Ill Intensive Care Unit Patients
- Keywords
- candida, intra-abdominal candidiasis, abdominal surgery, pharmacokinetics, pharmacodynamics
- Medical subject headings
- Intraabdominal Infections, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult critically ill patients with suspected or confirmed intra-abdominal candidiasis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal/Plasma Penetration Ratio of Rezafungin
Penetration ratio of rezafungin will be calculated as the ratio of the area under the concentration-time curve from 0 to 3 hours (AUC₀-₃h) in peritoneal fluid compared to plasma in critically ill patients undergoing abdominal surgery for suspected or proven intra-abdominal candidiasis
Measured: From 0 to 3 hours after rezafungin administration
Secondary outcomes (6)
Plasma Concentration-Time Profile of Rezafungin
Area under the concentration-time curve (AUC) of rezafungin in plasma will be calculated over three time intervals: AUC₀-₂₄h, AUC₀-₄₈h, and AUC₀-₁₆₈h to describe the evolution of plasma concentrations during treatment
Measured: From 0 to 168 hours after the first rezafungin administration
Peritoneal Concentration-Time Profile of Rezafungin
Area under the concentration-time curve (AUC) of rezafungin in peritoneal fluid will be calculated over two time intervals: AUC₀-₂₄h and AUC₀-₄₈h to describe the evolution of peritoneal concentrations during treatment.
Measured: From 0 to 48 hours after the first rezafungin administration
Pharmacokinetic target attainment of rezafungin concentration in plasma at the time of surgery
Proportion of patients achieving the predefined pharmacokinetic target at H3, defined as a plasma rezafungin concentration ≥1 mg/L, assessed using both total and free plasma concentrations
Measured: At the time of abdominal surgery (within the first 3 hours after rezafungin administration)
Pharmacokinetic target attainment of rezafungin concentration in plasma during the postoperative period
Proportion of patients achieving the predefined pharmakinetic target at H3, H6, H12, H24 and H48, defined as a plasma rezafungin concentration ≥1 mg/L, assessed using both total and free plasma concentrations
Measured: From 0 to 168 hours after the first rezafungin administration
To identify pharmacokinetic factors associated with the attainment of rezafungin target concentrations in plasma
Association between clinical, biological and treatment-related factors and attainment of the predefined rezafungin pharmacodynamic target at H24 and H48
Measured: From 0 to 48 hours after the first rezafungin administration
Association Between Pharmacodynamic Target Attainment and Day-28 In-Hospital Mortality
In-hospital mortality at Day 28 according to attainment or non-attainment of the predefined pharmacodynamic targets during treatment (H3, H6, H12, H24 and H48), and at H168 according to Candida species
Measured: From rezafungin administration to Day 28 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start14 Nov 2025
- Primary completion24 Sep 2026
- Study completion24 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-Abdominal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Mundipharma Research GmbH & Co KG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093203
- Sponsor's protocol ID
- 2024PI230
- Acronym
- REAREZ
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic of Rezafungin in the Plasma and the Peritoneal Fluid of Critically Ill Patients With Intra-abdominal Candidiasis Requiring Abdominal Surgery
- ClinicalTrials.gov ID
- NCT07093203
- Acronym / sponsor ID
- REAREZ / 2024PI230
- Conditions
- Intra-Abdominal Infection, Candida, Abdominal Surgery Patients, Critically Ill Intensive Care Unit Patients
- Keywords
- candida, intra-abdominal candidiasis, abdominal surgery, pharmacokinetics, pharmacodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Mundipharma Research GmbH & Co KG
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 24 Sep 2026 (actual)
- Study completion
- 24 Sep 2026 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ntra-abdominal candidiasis is a serious infection common in critically ill patients, often leading to high mortality if not treated quickly. Standard antifungal treatments may be less effective due to growing resistance and poor drug penetration into the abdominal cavity. In critically ill patients, drug levels can vary widely due to factors like surgery, inflammation, fluid resuscitation, or extracorporeal support, increasing the risk of underdosing. Rezafungin is a new antifungal agent with a long half-life and broad activity against Candida species, offering potential advantages in this setting. However, there is currently no data on its concentration or effectiveness in the peritoneal fluid of patients with intra-abdominal sepsis. Its long half-life, coupled with repeated pharmacokinetic variations in critical care settings and the risk of insufficient concentrations, may hinder its use in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult critically ill patients with suspected or confirmed intra-abdominal candidiasis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective PK study of critically ill adult patients with proven or suspected intra-abdominal candidiasis who are admitted to the surgical ICU at the university hospital of Nancy (France). Adult critically ill patients with suspected intra-abdominal candidiasis requiring abdominal surgery and administration of rezafungin as first-line empirical antifungal treatment just before the abdominal surgery, abdominal drain for at least 2 days after the surgery. Intra-abdominal candidiasis is defined following the 2024 consensus of FUNDICU
Key inclusion criteria (4 listed)
- age > 18 years
- with a suspected intra-abdominal candidiasis requiring abdominal surgery
- and receiving the administration of rezafungin as first-line empirical antifungal treatment just before or within 1 hour the abdominal surgery
- and having abdominal drain for at least 2 days after the surgery
Key exclusion criteria (2 listed)
- death expected within 24h
- decline to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peritoneal/Plasma Penetration Ratio of Rezafungin
Time frame: From 0 to 3 hours after rezafungin administration
Penetration ratio of rezafungin will be calculated as the ratio of the area under the concentration-time curve from 0 to 3 hours (AUC₀-₃h) in peritoneal fluid compared to plasma in critically ill patients undergoing abdominal surgery for suspected or proven intra-abdominal candidiasis
6 secondary outcomes
Plasma Concentration-Time Profile of Rezafungin
Time frame: From 0 to 168 hours after the first rezafungin administration
Peritoneal Concentration-Time Profile of Rezafungin
Time frame: From 0 to 48 hours after the first rezafungin administration
Pharmacokinetic target attainment of rezafungin concentration in plasma at the time of surgery
Time frame: At the time of abdominal surgery (within the first 3 hours after rezafungin administration)
Pharmacokinetic target attainment of rezafungin concentration in plasma during the postoperative period
Time frame: From 0 to 168 hours after the first rezafungin administration
To identify pharmacokinetic factors associated with the attainment of rezafungin target concentrations in plasma
Time frame: From 0 to 48 hours after the first rezafungin administration
Association Between Pharmacodynamic Target Attainment and Day-28 In-Hospital Mortality
Time frame: From rezafungin administration to Day 28 post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-Abdominal Infection and Candida, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal/Plasma Penetration Ratio of Rezafungin (time frame: From 0 to 3 hours after rezafungin administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.