Innate Immune Response Monitoring Via Monocyte HLA-DR in Severe Intra-abdominal Infections at Risk of Fungal Infection

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Immunomonitoring

    Other intervention

    To analyse monocyte HLA-DR expression (mHLA-DR) and CD4+ T lymphocyte count (CD4) in both group

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intra-abdominal candidiasis1 intervention
Group B: Bacterial Intra-abdominal infection1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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Central Hospital, Nancy, France

Lead sponsor

Hospices Civils de Lyon

Collaborator