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NCT Number: NCT07130799

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

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.

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Key information

Conditions

Intra-abdominal Infection Candida Sepsis Critical Illness Disease Attributes Immunization; Sepsis Infections Inflammation Intraabdominal Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Op Infection Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de NANCY

Vandœuvre-lès-Nancy, 54500, France

Location status: Recruiting

Location contact

Anne-Claire LUKASZEWICZ, MD,PhD

PRINCIPAL_INVESTIGATOR

Emmanuel NOVY, MD, PhD

CONTACT

[email protected]

+33 383157437

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunomonitoring

Other

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

Primary outcomes

  1. Correlation Between percentage of Monocyte HLA-DR Expression and the Occurrence of Intra-abdominal Candidiasis

    Time frame: Within 7 days after abdominal surgery

    Assessment of the relationship between monocyte HLA-DR expression levels and the development of intra-abdominal candidiasis in critically ill patients with severe intra-abdominal infection.

Secondary outcomes

  1. Change Over Time in Percentage of Monocytes Expressing HLA-DR Measured by Flow Cytometry in Patients With vs Without Intra-abdominal Candidiasis

    Time frame: From Day 0 (surgery) to Day 7 post-surgery

    Peripheral venous blood will be collected at Day 0 (within 6 hours after index surgery), Day 3, Day 5, and Day 7 post-surgery.

    Monocyte HLA-DR expression will be quantified as the percentage of CD14+/CD16-/low monocytes positive for HLA-DR using standardized flow cytometry with anti-HLA-DR monoclonal antibody.

    Results will be compared between patients with confirmed intra-abdominal candidiasis (peritoneal culture positive for Candida) and those with intra-abdominal infection without fungal involvement.

    Primary analysis: between-group difference in change from baseline (Day 0) to Day 7 in percentage of HLA-DR+ monocytes

  2. Variation in Lymphocyte Subpopulations Based on Presence or Absence of Intra-abdominal Candidiasis

    Time frame: From Day 0 (surgery) to Day 7 post-surgery

    Analysis of the changes in lymphocyte subpopulations counts (CD4+ T cells, CD8+ T cells, NK cells, B cells) in patients with versus without intra-abdominal candidiasis

  3. Impact of Immune Dysfunction on In-Hospital Mortality

    Time frame: From surgery to Day 28

    Evaluation of the correlation between low HLA-DR expression and in-hospital mortality

  4. Impact of Immune Dysfunction on Source Control of Infection

    Time frame: Up to 28 days

    Assessment of whether immune dysfunction (defined by a low expression level of HLA-DR) is associated with failure or delay in achieving effective surgical or medical source control of the intra-abdominal infection

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • Hospices Civils de Lyon

Registry information

Official study title

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

Acronym: CANDIRIS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 19, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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