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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHRU de NANCY
  Vandœuvre-lès-Nancy, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.