Unraveling the Pathogenesis of Influenza-associated Aspergillosis: a Single-center, Prospective Cohort Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Influenza With Pneumonia
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Difference in immune cell profile in blood between influenza and non-influenza CAPIV patients at ICU.
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
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.
Secondary Outcomes
- Correlation of findings with outcome(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))
- Longitudinal differences in anatomopathological characteristics of the respiratory tract in CAPIV +/- influenza(through study completion, after 3 influenza seasons (3 years))
- 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))