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

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · Aug 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a serious type of fungal infection called intra-abdominal candidiasis (IAC), which can happen in patients who are very sick with infections inside the belly, especially after surgery. The researchers want to understand why some patients develop this severe fungal infection while others do not. They are looking at a part of the immune system called monocyte HLA-DR — a marker that shows how well the body’s first line of defense is working. By measuring this marker, they hope to find out if patients who get the fungal infection have weaker immune responses compared to those with only bacterial infections. This could help doctors identify at-risk patients earlier and improve their care.

Adults who are seriously ill with a severe infection inside their abdomen and need urgent surgery may be eligible to join the study. Key points for eligibility include having had recent abdominal surgery, certain types of infections, or other risk factors like taking strong antibiotics or experiencing septic shock (a severe body-wide infection). Participants will be closely monitored in the hospital, with blood tests to measure their immune response, but the study does not involve new treatments. It aims to improve understanding of immune changes in these patients to help future care. If you or a loved one fits these criteria and are interested, the medical team will provide full information before any decision is made.

Gender

ALL

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