Influenza Associated Aspergillosis In-depth Investigation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
This trial is aimed to study the immunological and pathological characteristics of influenza versus non-influenza severe community-acquired pneumonia patients in ICU.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Age < 18 years old
Pregnant women
No informed consent
Trial population
Critically ill community-acquired pneumonia patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
45 Participants
are grouped into 2 trial groupsGroup A: Influenza positive CAPIV
Group B: Influenza negative CAPIV
Trial outcomes
Primary outcomes
1
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.
Time frame
through study completion, after 3 influenza seasons (3 years)2
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.
Time frame
through study completion, after 3 influenza seasons (3 years)3
Difference in function of blood neutrophils between influenza and non-influenza CAPIV patients at ICU.
Functional analysis by killing assay will be performed.
Time frame
through study completion, after 3 influenza seasons (3 years)4
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.
Time frame
through study completion, after 3 influenza seasons (3 years)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.
Longitudinal alterations in advanced immunophenotyping results and (fungal) cell stimulation will be analysed and compared between groups.
Time frame
through study completion, after 3 influenza seasons (3 years)2
Longitudinal differences in anatomopathological characteristics of the respiratory tract in CAPIV +/- influenza
Respiratory tract biopsies will be compared longitudinally throughout the disease course.
Time frame
through study completion, after 3 influenza seasons (3 years)3
Correlation of findings with invasive pulmonary aspergillosis incidence
All data will be compared within each group between patients that develop IPA vs no development of IPA.
Time frame
through study completion, after 3 influenza seasons (3 years)4
Correlation of findings with outcome
All data will be compared to outcome measures (length of ICU stay, mortality, etc) to find hallmarks of severe disease.
Time frame
through study completion, after 3 influenza seasons (3 years)Sponsors and contacts
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Source ClinicalTrials.gov