Clinical trial NCT03748069: Influenza Associated Aspergillosis In-depth Investigation
Official title: Unraveling the Pathogenesis of Influenza-associated Aspergillosis: a Single-center, Prospective Cohort Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Influenza With Pneumonia
Invasive Pulmonary Aspergillosis
Keywords: Influenza
IPA
ICU
Immunology
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill community-acquired pneumonia patients

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.

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

Primary outcomes:
measure: Difference in immune cell profile in blood between influenza and non-influenza CAPIV patients at ICU.
timeFrame: through study completion, after 3 influenza seasons (3 years)
measure: Difference in cytokine production of mononuclear cells to fungal stimulation in blood between influenza and non-influenza CAPIV patients at ICU.
timeFrame: through study completion, after 3 influenza seasons (3 years)
measure: Difference in function of blood neutrophils between influenza and non-influenza CAPIV patients at ICU.
timeFrame: through study completion, after 3 influenza seasons (3 years)
measure: Difference in in immune cell profile in BAL fluid between influenza and non-influenza CAPIV patients at ICU.
timeFrame: through study completion, after 3 influenza seasons (3 years)
measure: Difference in cytokine production of mononuclear cells to fungal stimulation in BAL fluid between influenza and non-influenza CAPIV patients at ICU.
timeFrame: through study completion, after 3 influenza seasons (3 years)
measure: Difference in function of BAL fluid neutrophils between influenza and non-influenza CAPIV patients at ICU.
timeFrame: through study completion, after 3 influenza seasons (3 years)
measure: Difference in pathological hallmarks between influenza and non-influenza CAPIV patients at ICU.
timeFrame: through study completion, after 3 influenza seasons (3 years)
Secondary outcomes:
measure: 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.
timeFrame: through study completion, after 3 influenza seasons (3 years)
measure: Longitudinal differences in anatomopathological characteristics of the respiratory tract in CAPIV +/- influenza
timeFrame: through study completion, after 3 influenza seasons (3 years)
measure: Correlation of findings with invasive pulmonary aspergillosis incidence
timeFrame: through study completion, after 3 influenza seasons (3 years)
measure: Correlation of findings with outcome
timeFrame: through study completion, after 3 influenza seasons (3 years)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
Study officials:
affiliation: UZ Leuven
name: Joost Wauters, PhD
role: PRINCIPAL_INVESTIGATOR
References: