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NCT Number: NCT03748069

Influenza Associated Aspergillosis In-depth Investigation

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

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Key information

Conditions

Influenza With Pneumonia Aspergillosis Bacterial Infections and Mycoses Infections Influenza, Human Invasive Fungal Infections Invasive Pulmonary Aspergillosis Lung Diseases Lung Diseases, Fungal Mycoses Orthomyxoviridae Infections Pulmonary Aspergillosis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location status: Recruiting

Location contact

Joost Wauters, PhD

CONTACT

[email protected]

16344275 ext. +32

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Difference in immune cell profile in blood between influenza and non-influenza CAPIV patients at ICU.

    Time frame: 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.

  2. Difference in cytokine production of mononuclear cells to fungal stimulation in blood between influenza and non-influenza CAPIV patients at ICU.

    Time frame: 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.

  3. Difference in function of blood neutrophils between influenza and non-influenza CAPIV patients at ICU.

    Time frame: through study completion, after 3 influenza seasons (3 years)

    Functional analysis by killing assay will be performed.

  4. Difference in in immune cell profile in BAL fluid between influenza and non-influenza CAPIV patients at ICU.

    Time frame: 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.

  5. Difference in cytokine production of mononuclear cells to fungal stimulation in BAL fluid between influenza and non-influenza CAPIV patients at ICU.

    Time frame: 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.

  6. Difference in function of BAL fluid neutrophils between influenza and non-influenza CAPIV patients at ICU.

    Time frame: through study completion, after 3 influenza seasons (3 years)

    Functional analysis by killing assay will be performed.

  7. Difference in pathological hallmarks between influenza and non-influenza CAPIV patients at ICU.

    Time frame: through study completion, after 3 influenza seasons (3 years)

    Biopsies of respiratory tract tissue will be compared between two groups.

Secondary outcomes

  1. 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.

    Time frame: 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.

  2. Longitudinal differences in anatomopathological characteristics of the respiratory tract in CAPIV +/- influenza

    Time frame: through study completion, after 3 influenza seasons (3 years)

    Respiratory tract biopsies will be compared longitudinally throughout the disease course.

  3. Correlation of findings with invasive pulmonary aspergillosis incidence

    Time frame: through 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.

  4. Correlation of findings with outcome

    Time frame: through 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joost Wauters, PhD

CONTACT

[email protected]

16344275 ext. +32

Lore Vanderbeke, MD

CONTACT

[email protected]

16344275 ext. +32

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: PIAS

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2018
Registry last updated
Nov 17, 2025

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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