RecruitingNCT07130799

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


Sponsor

Central Hospital, Nancy, France

Enrollment

100 participants

Start Date

Nov 14, 2025

Study Type

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

Min Age: 18 Years

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

OTHERImmunomonitoring

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


Locations(1)

CHRU de NANCY

Vandœuvre-lès-Nancy, France

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NCT07130799


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