Influenza Associated Aspergillosis In-depth Investigation

Recruiting

• Conditions: Invasive Pulmonary Aspergillosis; Influenza With Pneumonia

• Registration Number: NCT03748069
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-20
• Study Start: 2019-01-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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 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 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.

Secondary Outcome Measures

Name	Time	Method
Correlation of findings with outcome	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.
Correlation of findings with invasive pulmonary aspergillosis incidence	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.
Longitudinal differences in anatomopathological characteristics of the respiratory tract in CAPIV +/- influenza	through study completion, after 3 influenza seasons (3 years)	Respiratory tract biopsies will be compared longitudinally throughout the disease course.
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.

Trial Locations

Locations (1)

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Belgium