Monocyte HLA-DR monitoring to detect immune weakness in severe intra-abdominal infections at risk for fungal invasion

Evaluation of the Innate Immune Response Through Monocyte HLA-DR Monitoring During Severe Intra-abdominal Candidiasis in the Critically Ill Patients

This will test whether measuring monocyte HLA-DR can reveal innate immune weakness in adult ICU patients with severe intra‑abdominal infections who are at risk for invasive Candida.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Central Hospital, Nancy, France (other)
• Locations: 1 site (Vandœuvre-lès-Nancy)
• Trial ID: NCT07130799 on ClinicalTrials.gov

What this trial studies

This is an observational immunomonitoring protocol enrolling adult ICU patients undergoing urgent surgery for severe intra‑abdominal infection and at least one risk factor for intra‑abdominal candidiasis. Blood samples will be taken to measure monocyte HLA‑DR expression as a marker of innate immune function and compared between patients who develop intra‑abdominal candidiasis and those with severe bacterial intra‑abdominal infections. The aim is to determine whether a deeper or more prolonged drop in HLA‑DR is associated with invasive fungal infection, which could inform earlier risk stratification. No investigational drug is given; the study uses laboratory immune profiling alongside routine clinical care.

Who should consider this trial

Good fit: Adults (≥18) admitted to ICU or intermediate care for severe intra‑abdominal infection requiring urgent abdominal surgery who have one or more risk factors for intra‑abdominal candidiasis or a high peritonitis score are ideal candidates.

Not a fit: Patients who are not critically ill, managed without surgery (e.g., radiologic drainage only), moribund with expected imminent death, or those without risk factors for intra‑abdominal candidiasis are unlikely to gain direct benefit from this observational monitoring.

Why it matters

Potential benefit: If successful, the findings could enable earlier identification of patients at high risk for invasive Candida and guide more timely antifungal or supportive interventions.

How similar studies have performed: Previous critical‑care studies have shown that low monocyte HLA‑DR correlates with immune suppression and worse outcomes in sepsis, but its specific predictive value for intra‑abdominal candidiasis remains incompletely validated.

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

Where this trial is running

Vandœuvre-lès-Nancy

• CHRU de NANCY — Vandœuvre-lès-Nancy, France (RECRUITING)

Conditions: Intra-abdominal Infection, Critical Illness, Post-Op Infection, Immunization, Sepsis, Candida Sepsis, intra-abdominal infection, intra-abdominal candidiasis