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

NCT ID: NCT07130799

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-03-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intra-abdominal candidiasis

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

Immunomonitoring

Intervention Type: OTHER

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

Bacterial Intra-abdominal infection

Intra-abdominal infection with a negative fungal culture

Immunomonitoring

Intervention Type: OTHER

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

Interventions

Immunomonitoring

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Central Hospital

Vandœuvre-lès-Nancy, , France

Countries

France

Other Identifiers

2024PI208

Identifier Type: -

Identifier Source: org_study_id