An observational study in Intra-Abdominal Infection, Candida and Abdominal Surgery Patients, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Central Hospital, Nancy, France · Observational
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Among 20 studies in Intraabdominal Infections with a site in France — 1 open to participants now, 1 under way, none of them phase 3. Intraabdominal Infections · France.
Among the 20 studies in Intraabdominal Infections with a site in France, this one is one of 3 that started in 2025, is one of 9 observational ones, and was the 19th registered.
129 studies on the registry are indexed under Intraabdominal Infections; 15 are open to participants now.
Browse Intraabdominal Infections studies →1 of the 20 studies in Intraabdominal Infections with a site in France is open now. Recruiting first, the newest first:
Central Hospital, Nancy, France · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 10 Intraabdominal Infections studies recruiting now, 6 (60%) set no upper age limit and 3 (30%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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20 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 18 is below the median of 174 across 48 observational studies indexed under Intraabdominal Infections.
Median enrollment 204 across the 11 interventional studies, 200 across the 9 observational. Of the 18 that completed or were terminated, 7 (39%) have results posted.
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11 of 20 have an industry lead sponsor. The 10 most frequent:
Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
Central Hospital, Nancy, France has 5 studies filed under Intraabdominal Infections — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Intraabdominal Infections with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: From 0 to 3 hours after rezafungin administration
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
Time frame: 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.
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
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
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
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
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
Association between clinical, biological and treatment-related factors and attainment of the predefined rezafungin pharmacodynamic target at H24 and H48
Time frame: 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
Time frame: From rezafungin administration to Day 28 post-treatment
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2025 to primary completion in Sep 2026, 10 months.
Of 24 observational studies under Intraabdominal Infections, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's 10 months is below that.
Primary completion moved once since we started tracking on Sep 25, 2026: Jul 2026 → Sep 2026, on Oct 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France →