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Influenza Associated Aspergillosis In-depth Investigation

Unraveling the Pathogenesis of Influenza-associated Aspergillosis: a Single-center, Prospective Cohort Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03748069
Acronym
PIAS
Enrollment
45
Registered
2018-11-20
Start date
2019-01-18
Completion date
2027-04-30
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza With Pneumonia, Invasive Pulmonary Aspergillosis

Keywords

Influenza, IPA, ICU, Immunology

Brief summary

This trial is aimed to study the immunological and pathological characteristics of influenza versus non-influenza severe community-acquired pneumonia patients in ICU.

Detailed description

This trial is aimed to study the immunological and pathological characteristics of influenza versus non-influenza severe community-acquired pneumonia patients in ICU, and correlate findings with occurrence of secondary invasive pulmonary aspergillosis infection. All consecutive patients aged 18 or older admitted to ICU during the inclusion period with respiratory distress due to influenza positive/negative community acquired pneumonia (CAP) will be included.

Interventions

None listed

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients older than 18 years, admitted to ICU with respiratory distress with microbiologically confirmed diagnosis of influenza (for inclusion in the influenza group) * All patients older than 18 years, admitted to ICU for respiratory distress due to community- acquired pneumonia , with a microbiologically confirmed absence of influenza (for inclusion in the control group)

Exclusion criteria

* Age \< 18 years old * Pregnant women * No informed consent

Design outcomes

Primary

MeasureTime frameDescription
Difference in function of BAL fluid neutrophils between influenza and non-influenza CAPIV patients at ICU.through study completion, after 3 influenza seasons (3 years)Functional analysis by killing assay will be performed.
Difference in function of blood neutrophils between influenza and non-influenza CAPIV patients at ICU.through study completion, after 3 influenza seasons (3 years)Functional analysis by killing assay will be performed.
Difference in in immune cell profile in BAL fluid between influenza and non-influenza CAPIV patients at ICU.through study completion, after 3 influenza seasons (3 years)Immunophenotyping of BAL fluid will be performed to determine number of neutrophils, T- and B-cell subsets, NK cell and myeloid cell subsets. Difference in influenza positive and influenza negative patients is expected.
Difference in pathological hallmarks between influenza and non-influenza CAPIV patients at ICU.through study completion, after 3 influenza seasons (3 years)Biopsies of respiratory tract tissue will be compared between two groups.
Difference in cytokine production of mononuclear cells to fungal stimulation in BAL fluid between influenza and non-influenza CAPIV patients at ICU.through study completion, after 3 influenza seasons (3 years)Key cytokine reaction of mononuclear BAL fluid cells after fungal stimulation will be performed. Difference in influenza positive and influenza negative patients is expected.
Difference in immune cell profile in blood between influenza and non-influenza CAPIV patients at ICU.through study completion, after 3 influenza seasons (3 years)Immunophenotyping of blood will be performed to determine number of neutrophils, T- and B-cell subsets, NK cell and myeloid cell subsets. Difference in influenza positive and influenza negative patients is expected.
Difference in cytokine production of mononuclear cells to fungal stimulation in blood between influenza and non-influenza CAPIV patients at ICU.through study completion, after 3 influenza seasons (3 years)Key cytokine reaction of mononuclear cells (PBMC) after fungal stimulation will be performed. Difference in influenza positive and influenza negative patients is expected.

Secondary

MeasureTime frameDescription
Longitudinal differences in anatomopathological characteristics of the respiratory tract in CAPIV +/- influenzathrough study completion, after 3 influenza seasons (3 years)Respiratory tract biopsies will be compared longitudinally throughout the disease course.
Correlation of findings with invasive pulmonary aspergillosis incidencethrough study completion, after 3 influenza seasons (3 years)All data will be compared within each group between patients that develop IPA vs no development of IPA.
Correlation of findings with outcomethrough study completion, after 3 influenza seasons (3 years)All data will be compared to outcome measures (length of ICU stay, mortality, etc) to find hallmarks of severe disease.
Difference in longitudinal alterations in phagocytic cell and mononuclear inflammatory cell subsets in blood and BAL fluid and their response to fungal stimulation between the main study arms.through study completion, after 3 influenza seasons (3 years)Longitudinal alterations in advanced immunophenotyping results and (fungal) cell stimulation will be analysed and compared between groups.

Countries

Belgium

Contacts

Primary ContactJoost Wauters, PhD
joost.wauters@uzleuven.be16344275
Backup ContactLore Vanderbeke, MD
lore.vanderbeke@uzleuven.be16344275

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026