About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient (≥ 18 years old)
Patient admitted to the ICU or intermediate care unit for a severe intra-abdominal infection requiring urgent abdominal surgery
Abdominal surgery within the last 7 days
Supramesocolic gastrointestinal perforation
Disqualifiers
Radiologically guided drainage without surgery
Infected acute pancreatitis
Limitation or withdrawal of life-sustaining treatments
Moribund patient with an expected life expectancy < 48 hours
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Immunomonitoring
Other interventionTo analyse monocyte HLA-DR expression (mHLA-DR) and CD4+ T lymphocyte count (CD4) in both group
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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
Impact of Immune Dysfunction on In-Hospital Mortality
Evaluation of the correlation between low HLA-DR expression and in-hospital mortality
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
Sponsors and contacts
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Central Hospital, Nancy, France
Lead sponsor
Hospices Civils de Lyon
Collaborator