Influenza Associated Aspergillosis In-depth Investigation (PIAS)

March 27, 2023 updated by: Universitaire Ziekenhuizen KU Leuven

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Universitaire Ziekenhuizen Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critically ill community-acquired pneumonia patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Influenza positive CAPIV
All consecutive patients older than 18 years, admitted to the ICU with respiratory distress with microbiologically confirmed diagnosis of influenza
Influenza negative CAPIV
All consecutive patients older than 18 years, admitted to the ICU for respiratory distress due to community-acquired pneumonia (CAP) and with a microbiologically confirmed absence of influenza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, after 3 influenza seasons (3 years)
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.
through study completion, after 3 influenza seasons (3 years)
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.
through study completion, after 3 influenza seasons (3 years)
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.
through study completion, after 3 influenza seasons (3 years)
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.
through study completion, after 3 influenza seasons (3 years)
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.
through study completion, after 3 influenza seasons (3 years)
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.
through study completion, after 3 influenza seasons (3 years)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2019

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

November 16, 2018

First Posted (Actual)

November 20, 2018

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Invasive Pulmonary Aspergillosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe