跳至主要内容
临床试验/NCT07330986
NCT07330986已完成不适用

Influenza A-associated Pulmonary Aspergillosis in Patients Admitted to the Intensive Care Unit in China: a Retrospective Cohort Study

Jianfeng Xie1 个研究点 分布在 1 个国家目标入组 542 人开始时间: 2025年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
542
试验地点
1
主要终点
60-day mortality

研究概览

简要总结

Invasive pulmonary aspergillosis (IPA) has traditionally been considered a disease of the severely immunocompromised host. However, emerging evidence over the past decade has identified severe influenza as a significant risk factor for IPA, termed influenza-associated pulmonary aspergillosis (IAPA) . The reported incidence of IAPA in ICU patients ranges from 11% to 32%, with associated mortality exceeding 50% in some cohorts.

The pathophysiology of IAPA is thought to involve influenza virus-induced damage to the respiratory epithelium, which impairs mucociliary clearance and disrupts local immune defenses, thereby facilitating invasion by aspergillus species. Studies from recent influenza seasons report IAPA incidences ranging from 16% to 23% in critically ill patients, with associated mortality rates soaring to over 50% . This mortality is substantially higher than that observed in influenza patients without IPA, underscoring the severity of this co-infection.

Despite this recognized threat, significant knowledge gaps remain. Existing studies on IAPA are predominantly single-center or include a limited number of patients, with considerable heterogeneity in their outcomes, constraining the generalizability of their findings . A comprehensive understanding of the specific risk factors that predispose influenza patients to IPA is crucial for early identification and intervention. Furthermore, the clinical course and determinants of mortality specifically within the IAPA population are not yet fully elucidated.

Therefore, we We conducted a retrospective, multicenter cohort study across 20 ICUs in China. Patients were categorized into IPA and non-IPA groups based on FUNDICU diagnostic criteria (clinical, radiological, and mycological evidence) to describe the risk factors, clinical characteristics and outcomes of critically ill patients with IAPA.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients (≥18 years)
  • patients admitted to the ICU between November 1, 2024, and February 28, 2025
  • patients with acute respiratory failure due to laboratory-confirmed Influenza A pneumonia (defined by a positive PCR test on respiratory specimens)

排除标准

  • patients with readmission to the ICU
  • patients with incomplete clinical data

结局指标

主要结局

60-day mortality

时间窗: From day 1 to day 60 after ICU admission

次要结局

未报告次要终点

研究者

发起方
Jianfeng Xie
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jianfeng Xie

Professor

Southeast University, China

研究点 (1)

Loading locations...

相似试验

Influenza A-associated Pulmonary Aspergillosis in... | 临床试验