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Completed

NCT Number: NCT07330986

Influenza A-associated Pulmonary Aspergillosis in Patients Admitted to the Intensive Care Unit in China

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jiangsu Provincial Key Laboratory of Critical Care Medicine, Department of Critical Care Medicine, Zhongda Hospital, Southeast University

Nanjing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

IPA and non-IPA groups

Other

Patients were divided into IPA and non-IPA groups according to FUNDICU criteria.

Primary outcomes

  1. 60-day mortality

    Time frame: From day 1 to day 60 after ICU admission

Sponsors and collaborators

Lead sponsor

Jianfeng Xie

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2026
Registry last updated
Jan 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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