An observational study in Intra-abdominal Infection, Critical Illness and Post-Op Infection, sponsored by Central Hospital, Nancy, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Central Hospital, Nancy, France · Observational
Intra-abdominal candidiasis (IAC) is a frequent and severe fungal infection in critically ill patients, often diagnosed late. Its pathophysiology remains unclear, particularly regarding why some patients develop invasive infection while others only show benign colonization. A potential explanation lies in the state of innate immunity. Monocyte HLA-DR expression, a recognized marker of immune suppression in critical care, may be transiently but profoundly reduced in non-immunocompromised patients who go on to develop IAC. This observational study aims to evaluate whether patients with IAC have greater innate immune dysfunction-assessed by HLA-DR expression-compared to those with severe bacterial intra-abdominal infections. The goal is to better understand the immune mechanisms involved and improve early risk stratification for IAC.
129 studies on the registry are indexed under Intraabdominal Infections; 15 are open to participants now.
This study's planned enrollment of 100 is below the median of 174 across 48 observational studies indexed under Intraabdominal Infections.
Browse Intraabdominal Infections studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
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This study will include adult patients (≥18 years) admitted to the intensive care unit (ICU) for severe intra-abdominal infections requiring urgent abdominal surgery. Participants must present at least one recognized risk factor for intra-abdominal candidiasis, such as recent abdominal surgery, gastrointestinal perforation, healthcare-associated infection, immunosuppression, septic shock, or recent exposure to broad-spectrum antibiotics.
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.
Presence of at least one risk factor for intra-abdominal candidiasis:
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 weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intra-abdominal infection with intra-abdominal candidiasis based on the FUNDICU consensus
Other: Immunomonitoring
Intra-abdominal infection with a negative fungal culture
Other: Immunomonitoring
To analyse monocyte HLA-DR expression (mHLA-DR) and CD4+ T lymphocyte count (CD4) in both group
Correlation Between percentage of Monocyte HLA-DR Expression and the Occurrence of Intra-abdominal Candidiasis
Assessment of the relationship between monocyte HLA-DR expression levels and the development of intra-abdominal candidiasis in critically ill patients with severe intra-abdominal infection.
Time frame: Within 7 days after abdominal surgery
Change Over Time in Percentage of Monocytes Expressing HLA-DR Measured by Flow Cytometry in Patients With vs Without Intra-abdominal Candidiasis
Peripheral venous blood will be collected at Day 0 (within 6 hours after index surgery), Day 3, Day 5, and Day 7 post-surgery. Monocyte HLA-DR expression will be quantified as the percentage of CD14+/CD16-/low monocytes positive for HLA-DR using standardized flow cytometry with anti-HLA-DR monoclonal antibody. Results will be compared between patients with confirmed intra-abdominal candidiasis (peritoneal culture positive for Candida) and those with intra-abdominal infection without fungal involvement. Primary analysis: between-group difference in change from baseline (Day 0) to Day 7 in percentage of HLA-DR+ monocytes
Time frame: From Day 0 (surgery) to Day 7 post-surgery
Variation in Lymphocyte Subpopulations Based on Presence or Absence of Intra-abdominal Candidiasis
Analysis of the changes in lymphocyte subpopulations counts (CD4+ T cells, CD8+ T cells, NK cells, B cells) in patients with versus without intra-abdominal candidiasis
Time frame: From Day 0 (surgery) to Day 7 post-surgery
Impact of Immune Dysfunction on In-Hospital Mortality
Evaluation of the correlation between low HLA-DR expression and in-hospital mortality
Time frame: From surgery to Day 28
Impact of Immune Dysfunction on Source Control of Infection
Assessment of whether immune dysfunction (defined by a low expression level of HLA-DR) is associated with failure or delay in achieving effective surgical or medical source control of the intra-abdominal infection
Time frame: Up to 28 days
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Sep 2026, 9 months after the start.
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 planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
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Central Hospital, Nancy, France →