ICUNCT07330986
Influenza A-associated Pulmonary Aspergillosis in Patients Admitted to the Intensive Care Unit in China
An observational study of ICU and Invasive Pulmonary Aspergillosis, run by Jianfeng Xie at 1 site in China.
Trial summary
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) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU, Invasive Pulmonary Aspergillosis, Influenza A
- What is being tested?
- IPA and non-IPA groups
- How many people
- 542 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the ICU between November 1, 2024, and February 28, 2025, with acute respiratory failure due to laboratory-confirmed Influenza A pneumonia
Who may be able to join
- 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)
Who cannot join
- patients with readmission to the ICU
- patients with incomplete clinical data
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Key Laboratory of Critical Care Medicine, Department of Critical Care Medicine, Zhongda Hospital, Southeast University
Nanjing
About this study
Official title: Influenza A-associated Pulmonary Aspergillosis in Patients Admitted to the Intensive Care Unit in China: a Retrospective Cohort Study
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.
Read more
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.
- Conditions
- ICU, Invasive Pulmonary Aspergillosis, Influenza A
- Being tested
- IPA and non-IPA groups
- Medical subject headings
- Invasive Pulmonary Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPA and non-IPA groupsOther
Patients were divided into IPA and non-IPA groups according to FUNDICU criteria.
What is being measured
The primary outcome is the main question the study is designed to answer.
60-day mortality
Measured: From day 1 to day 60 after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Nov 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianfeng Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianfeng Xie, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330986
- Sponsor's protocol ID
- 2025ZDSYLL509-P01
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza A-associated Pulmonary Aspergillosis in Patients Admitted to the Intensive Care Unit in China: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07330986
- Acronym / sponsor ID
- 2025ZDSYLL509-P01
- Conditions
- ICU, Invasive Pulmonary Aspergillosis, Influenza A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- Jianfeng XieUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the ICU between November 1, 2024, and February 28, 2025, with acute respiratory failure due to laboratory-confirmed Influenza A pneumonia
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- patients with readmission to the ICU
- patients with incomplete clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPA and non-IPA groupsPatients were divided into IPA and non-IPA groups according to FUNDICU criteria. | Other | – |
Primary outcome
60-day mortality
Time frame: From day 1 to day 60 after ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU and Invasive Pulmonary Aspergillosis, run by Jianfeng Xie at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
60-day mortality (time frame: From day 1 to day 60 after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.