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

NCT07130799 | Recruiting

• 1 other identifier: 2024PI208
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intra-abdominal Infection; Critical Illness; Post-Op Infection; Immunization; Sepsis; Candida Sepsis

Keywords

intra-abdominal infection; intra-abdominal candidiasis; HLA-DR; immunomonitoring; monocyte; critically ill patients

Outcome Measures

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.

  Within 7 days after abdominal surgery

Secondary Outcomes (4)

• Change Over Time in Percentage of Monocytes Expressing HLA-DR Measured by Flow Cytometry in Patients With vs Without Intra-abdominal Candidiasis

  From Day 0 (surgery) to Day 7 post-surgery

• Variation in Lymphocyte Subpopulations Based on Presence or Absence of Intra-abdominal Candidiasis

  From Day 0 (surgery) to Day 7 post-surgery

• Impact of Immune Dysfunction on In-Hospital Mortality

  From surgery to Day 28

• Impact of Immune Dysfunction on Source Control of Infection

  Up to 28 days

Study Arms (2)

Intra-abdominal candidiasis

Intra-abdominal infection with intra-abdominal candidiasis based on the FUNDICU consensus

Other: Immunomonitoring

Bacterial Intra-abdominal infection

Intra-abdominal infection with a negative fungal culture

Other: Immunomonitoring

Interventions

Immunomonitoring OTHER

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

Bacterial Intra-abdominal infection; Intra-abdominal candidiasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Hospices Civils de Lyon: collaborator

Study Sites (1)

CHRU de NANCY

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

MeSH Terms

Conditions

Intraabdominal Infections; Critical Illness; Sepsis

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 19, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2025-11

Locations

FR (1)