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Recruiting NCT07130799

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

— Observational Intra-abdominal Infection Critical Illness Post-Op Infection Immunization; Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immunomonitoring.
Who it may be relevant to
Registry conditions: Intra-abdominal Infection, Critical Illness, Post-Op Infection, Immunization; Sepsis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Correlation Between percentage of Monocyte HLA-DR Expression and the Occurrence of Intra-abdominal Candidiasis [Time frame: Within 7 days after abdominal surgery]
Secondary outcome measures (4)
  • 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]
  • Variation in Lymphocyte Subpopulations Based on Presence or Absence of Intra-abdominal Candidiasis [Time frame: From Day 0 (surgery) to Day 7 post-surgery]
  • Impact of Immune Dysfunction on In-Hospital Mortality [Time frame: From surgery to Day 28]
  • Impact of Immune Dysfunction on Source Control of Infection [Time frame: Up to 28 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHRU de NANCY — Vandœuvre-lès-Nancy

Identifiers

NCT: NCT07130799 · 2024PI208

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗