Influenza Associated Aspergillosis In-depth Investigation

NCT03748069 | Recruiting

• 1 other identifier: PIAS
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza With Pneumonia; Invasive Pulmonary Aspergillosis

Keywords

Influenza; IPA; ICU; Immunology

Outcome Measures

Primary Outcomes (7)

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

  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.

  through study completion, after 3 influenza seasons (3 years)

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

  Key cytokine reaction of mononuclear cells (PBMC) after fungal stimulation will be performed. Difference in influenza positive and influenza negative patients is expected.

  through study completion, after 3 influenza seasons (3 years)

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

  Functional analysis by killing assay will be performed.

  through study completion, after 3 influenza seasons (3 years)

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

  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.

  through study completion, after 3 influenza seasons (3 years)

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

  Key cytokine reaction of mononuclear BAL fluid cells after fungal stimulation will be performed. Difference in influenza positive and influenza negative patients is expected.

  through study completion, after 3 influenza seasons (3 years)

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

  Functional analysis by killing assay will be performed.

  through study completion, after 3 influenza seasons (3 years)

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

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

  through study completion, after 3 influenza seasons (3 years)

Secondary Outcomes (4)

• 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 differences in anatomopathological characteristics of the respiratory tract in CAPIV +/- influenza

  through study completion, after 3 influenza seasons (3 years)

• Correlation of findings with invasive pulmonary aspergillosis incidence

  through study completion, after 3 influenza seasons (3 years)

• Correlation of findings with outcome

  through study completion, after 3 influenza seasons (3 years)

Study Arms (2)

Influenza positive CAPIV

All consecutive patients older than 18 years, admitted to the ICU with respiratory distress with microbiologically confirmed diagnosis of influenza

Influenza negative CAPIV

All consecutive patients older than 18 years, admitted to the ICU for respiratory distress due to community-acquired pneumonia (CAP) and with a microbiologically confirmed absence of influenza

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill community-acquired pneumonia patients

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, broncho-alveolar lavage fluid, lung tissue

MeSH Terms

Conditions

Invasive Pulmonary Aspergillosis; Influenza, Human

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Lung Diseases, Fungal; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Study Officials

• Joost Wauters, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joost Wauters, PhD

CONTACT

16344275; joost.wauters@uzleuven.be

Lore Vanderbeke, MD

CONTACT

16344275; lore.vanderbeke@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: November 20, 2018
• Study Start: January 18, 2019
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-10

Locations

BE (1)