Innate Immune Response Monitoring Via Monocyte HLA-DR in Severe Intra-abdominal Infections at Risk of Fungal Infection
Evaluation of the Innate Immune Response Through Monocyte HLA-DR Monitoring During Severe Intra-abdominal Candidiasis in the Critically Ill Patients
Central Hospital, Nancy, France
100 participants
Nov 14, 2025
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria12
- 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:
- Abdominal surgery within the last 7 days
- Supramesocolic gastrointestinal perforation
- Healthcare-associated intra-abdominal infection
- Community-acquired intra-abdominal infection in an immunocompromised patient*
- Intra-abdominal infection complicated by septic shock
- Broad-spectrum antibiotic exposure within 72 hours prior to surgery
- 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 Criteria6
- Radiologically guided drainage without surgery
- Infected acute pancreatitis
- Limitation or withdrawal of life-sustaining treatments
- Moribund patient with an expected life expectancy < 48 hours
- Woman of childbearing potential without effective contraception
- Refusal to participate in the study
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Interventions
To analyse monocyte HLA-DR expression (mHLA-DR) and CD4+ T lymphocyte count (CD4) in both group
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07130799