Influenza With PneumoniaPIASNCT03748069
Influenza Associated Aspergillosis In-depth Investigation
An observational study of Influenza With Pneumonia and Invasive Pulmonary Aspergillosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza With Pneumonia, Invasive Pulmonary Aspergillosis
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Jan 2019to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill community-acquired pneumonia patients
Who may be able to join
- 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)
Who cannot join
- Age < 18 years old
- Pregnant women
- No informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universitaire Ziekenhuizen Leuven
Leuven, 3000
Joost Wauters, PhD, 16344275 ext. +32, joost.wauters@uzleuven.be
About this study
Official title: 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.
Read the 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.
- Keywords
- Influenza, IPA, ICU, Immunology
- Medical subject headings
- Invasive Pulmonary Aspergillosis, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Key cytokine reaction of mononuclear cells (PBMC) after fungal stimulation will be performed. Difference in influenza positive and influenza negative patients is expected.
Measured: through study completion, after 3 influenza seasons (3 years)
Difference in function of blood neutrophils between influenza and non-influenza CAPIV patients at ICU.
Functional analysis by killing assay will be performed.
Measured: 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.
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.
Measured: 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.
Key cytokine reaction of mononuclear BAL fluid cells after fungal stimulation will be performed. Difference in influenza positive and influenza negative patients is expected.
Measured: 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.
Functional analysis by killing assay will be performed.
Measured: through study completion, after 3 influenza seasons (3 years)
Difference in pathological hallmarks between influenza and non-influenza CAPIV patients at ICU.
Biopsies of respiratory tract tissue will be compared between two groups.
Measured: through study completion, after 3 influenza seasons (3 years)
Secondary outcomes (4)
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.
Measured: through study completion, after 3 influenza seasons (3 years)
Longitudinal differences in anatomopathological characteristics of the respiratory tract in CAPIV +/- influenza
Respiratory tract biopsies will be compared longitudinally throughout the disease course.
Measured: through study completion, after 3 influenza seasons (3 years)
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.
Measured: through study completion, after 3 influenza seasons (3 years)
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.
Measured: through study completion, after 3 influenza seasons (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start18 Jan 2019
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza With PneumoniaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joost Wauters, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748069
- Sponsor's protocol ID
- PIAS
- Acronym
- PIAS
- Status last verified
- Oct 2025
- First submitted
- 4 Oct 2018
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling the Pathogenesis of Influenza-associated Aspergillosis: a Single-center, Prospective Cohort Pilot Study
- ClinicalTrials.gov ID
- NCT03748069
- Acronym / sponsor ID
- PIAS / PIAS
- Keywords
- Influenza, IPA, ICU, Immunology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill community-acquired pneumonia patients
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- Age < 18 years old
- Pregnant women
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 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.
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 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.
4 secondary outcomes
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 differences in anatomopathological characteristics of the respiratory tract in CAPIV +/- influenza
Time frame: 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)
Correlation of findings with outcome
Time frame: through study completion, after 3 influenza seasons (3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joost Wauters, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza With Pneumonia and Invasive Pulmonary Aspergillosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joost Wauters, PhD (16344275 ext. +32, joost.wauters@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.