Influenza Associated Aspergillosis In-depth Investigation

Invasive Pulmonary Aspergillosis Clinical Trial

— PIAS  

Official title:

Unraveling the Pathogenesis of Influenza-associated Aspergillosis: a Single-center, Prospective Cohort Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03748069
• Other study ID #: PIAS
• Status: Recruiting
• Start date: January 18, 2019
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Joost Wauters, PhD
• Phone: 16344275
• Email: joost.wauters[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This trial is aimed to study the immunological and pathological characteristics of influenza versus non-influenza severe community-acquired pneumonia patients in ICU.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Influenza With Pneumonia
• Influenza, Human
• Invasive Pulmonary Aspergillosis
• Pulmonary Aspergillosis

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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.	through study completion, after 3 influenza seasons (3 years)
Secondary	Longitudinal differences in anatomopathological characteristics of the respiratory tract in CAPIV +/- influenza	Respiratory tract biopsies will be compared longitudinally throughout the disease course.	through study completion, after 3 influenza seasons (3 years)
Secondary	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.	through study completion, after 3 influenza seasons (3 years)
Secondary	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.	through study completion, after 3 influenza seasons (3 years)