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| Name | Class |
|---|---|
| Hospices Civils de Lyon | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-abdominal candidiasis | Intra-abdominal infection with intra-abdominal candidiasis based on the FUNDICU consensus |
| |
| Bacterial Intra-abdominal infection | Intra-abdominal infection with a negative fungal culture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunomonitoring | Other | To analyse monocyte HLA-DR expression (mHLA-DR) and CD4+ T lymphocyte count (CD4) in both group |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 7 days after abdominal surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Adult patient (≥ 18 years old)
Patient admitted to the ICU or intermediate care unit for a severe intra-abdominal infection requiring urgent abdominal surgery
Presence of at least one risk factor for intra-abdominal candidiasis:
And/or a Peritonitis Score ≥ 3 out of 4
Patient affiliated with or benefiting from a national health insurance system
Patient who has received full information about the clinical study
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de NANCY | Recruiting | Vandœuvre-lès-Nancy | 54500 | France |
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| 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 | 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 | 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 | Up to 28 days |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D016638 | Critical Illness |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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