Actively Recruiting
Evaluation of the Innate Immune Response Through Monocyte HLA-DR Monitoring During Severe Intra-abdominal Candidiasis in Critically Ill Patients
Led by Central Hospital, Nancy, France · Updated on 2026-02-09
100
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
C
Central Hospital, Nancy, France
Lead Sponsor
H
Hospices Civils de Lyon
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying intra-abdominal candidiasis (IAC), a serious fungal infection often found in critically ill patients. This observational study aims to understand why some patients develop invasive IAC while others only have harmless colonization. It focuses on the role of innate immunity, specifically measuring monocyte HLA-DR expression, which may be reduced in patients who develop IAC compared to those with severe bacterial infections in the abdomen. The study involves monitoring patients with severe intra-abdominal infections, divided into two groups: those with IAC and those with bacterial intra-abdominal infections without fungal involvement. Researchers analyze immune markers like monocyte HLA-DR expression and CD4+ T lymphocyte counts. These assessments are done to compare immune function between the groups and better understand immune dysfunction related to fungal infection risk. Participants are patients admitted to intensive or intermediate care units for severe intra-abdominal infections requiring urgent surgery. Immune markers are measured from the day of surgery through seven days post-surgery. Researchers also track changes in immune cell populations, the impact of immune dysfunction on hospital outcomes up to 28 days, and correlate immune status with infection occurrence. The study helps improve early identification of patients at risk for invasive candidiasis and lasts from surgery through hospital stay with close immune monitoring.
CONDITIONS
Brief Title
Innate Immune Response Monitoring Via Monocyte HLA-DR in Severe Intra-abdominal Infections at Risk of Fungal Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient (≥ 18 years old)
- Patient admitted to ICU or intermediate care unit for severe intra-abdominal infection requiring urgent abdominal surgery
- Presence of at least one risk factor for intra-abdominal candidiasis, including 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, or 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 7 days after abdominal surgery
Participants undergo evaluation related to severe intra-abdominal infections and immune response monitoring including blood tests for monocyte HLA-DR expression and lymphocyte counts.
Daily visits from Day 0 (surgery) to Day 7 post-surgery
Duration - Up to 28 days after surgery
Participants are monitored for immune dysfunction impact on in-hospital mortality and infection source control.
Visits as needed during hospital stay up to 28 days
Trial Site Locations
Total: 1 location
1
CHRU de NANCY
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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