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Clinical Trials in France / NCT07130799
Recruiting Observational

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

NCT07130799 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-11-14
Last updated
2026-02-09

Condition(s) studied

Intra-abdominal InfectionCritical IllnessPost-Op InfectionImmunization; SepsisCandida Sepsis

Investigational drug(s) / intervention(s)

Immunomonitoring

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHRU de NANCY Vandœuvre-lès-Nancy France Recruiting

More Central Hospital, Nancy, France trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07130799 on ClinicalTrials.gov ↗ ← All trials in France