Evaluation of the Innate Immune Response Through Monocyte HLA-DR Monitoring During Severe Intra-abdominal Candidiasis in the Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Correlation Between percentage of Monocyte HLA-DR Expression and the Occurrence of Intra-abdominal Candidiasis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intra-abdominal candidiasis
Intra-abdominal infection with intra-abdominal candidiasis based on the FUNDICU consensus
干预措施: Immunomonitoring (Other)
Bacterial Intra-abdominal infection
Intra-abdominal infection with a negative fungal culture
干预措施: Immunomonitoring (Other)
结局指标
主要结局
Correlation Between percentage of Monocyte HLA-DR Expression and the Occurrence of Intra-abdominal Candidiasis
时间窗: 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.
次要结局
- Change Over Time in Percentage of Monocytes Expressing HLA-DR Measured by Flow Cytometry in Patients With vs Without Intra-abdominal Candidiasis(From Day 0 (surgery) to Day 7 post-surgery)
- Variation in Lymphocyte Subpopulations Based on Presence or Absence of Intra-abdominal Candidiasis(From Day 0 (surgery) to Day 7 post-surgery)
- Impact of Immune Dysfunction on In-Hospital Mortality(From surgery to Day 28)
- Impact of Immune Dysfunction on Source Control of Infection(Up to 28 days)