Influenza With PneumoniaIAPAFLUNCT04530799
Prospective Observational Trial of IAPA
An observational study of Influenza With Pneumonia and Pulmonary Aspergillosis, run by Radboud University Medical Center at 12 sites in 3 countries.
Trial summary
A prospective multi-center observational study to assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients and to identify host- and pathogen related risk factors for IAPA in EORTC negative ICU patients with severe influenza. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza With Pneumonia, Pulmonary Aspergillosis
- What is being tested?
- Identification of biomarkers for IAPA via patient sampling
- How many people
- 241 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 10 Mar 2022to 18 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The target patient population is the EORTC-negative population of critically ill influenza patients at ICU. Patient identification will rely on daily review of ICU patients with respiratory virus panels ordered in the previous 24 hours.
Who may be able to join
- Patients with a PCR-positive respiratory virus panel (RVP) result for influenza within 96 hours before or 48 hours after ICU admission.
- Patients who require ICU admission for more than 24 hours for severe influenza.
- Patients who have respiratory distress (respiratory rate >= 25x/minute and paO2/fiO2 < 300 with or without bilateral infiltrates) as the main reason for ICU admission.
- Patients who do not have an EORTC host factor.
- Patients who are at least 18 years of age.
Who cannot join
- Patients with age < 18 years as extensive sampling is required
- Expected survival on ICU admission ≤ 48h
- Patients that are being treated actively with antifungal agents for invasive aspergillosis.
- Patients or their legal representatives who did not sign the informed consent form
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
France6 sites
Amiens-Picardie University Hospital
Amiens, 80054
Centre Hospitalier REgional Universitaire de Lille
Lille
Henri Mondor Hopital
Paris
Hopital Bichat
Paris
Hopital Lariboisiere
Paris
Hopital Pontchaillou, Centre Hospitalier Universitaire de Rennes
Rennes
Netherlands3 sites
AmsterdamUMC, locatie VUmc
Amsterdam, 1081
Universitair Medisch Centrum Groningen
Groningen, Provincie Groningen, 9713
Radboudumc
Nijmegen, Gelderland, 6525GA
About this study
Official title: Influenza-associated Pulmonary Aspergillosis (IAPA) in ICU Patients With Severe Influenza: Incidence and Host- and Pathogen Related Risk Factors
A prospective multi-center observational study to assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients and to identify host- and pathogen related risk factors for IAPA in EORTC negative ICU patients with severe influenza.
Read the detailed description
Invasive pulmonary aspergillosis was shown to be a complication of severe influenza infections in immunocompromised patients as well as in immunocompetent patients and is associated with a high mortality. Antifungal prophylaxis might prevent influenza-associated pulmonary aspergillosis (IAPA) and thus might improve the outcome in patients with severe influenza. However, clinical related risk factors should be identified to assess whether a patient will benefit from antifungal prophylaxis. This prospective multi-center observational study will assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients in 12 ICUs in The Netherlands, Belgium and France over 4 influenza seasons. The secondary objective of this study is to identify host- and pathogen related risk factors for IAPA in EORTC negative ICU patients with severe influenza. Patients aged 18 or older admitted to the intensive care unit (ICU) during the inclusion period due severe influenza without classic risk factors defined by the EORTC will be included.
- Conditions
- Influenza With Pneumonia, Pulmonary Aspergillosis
- Being tested
- Identification of biomarkers for IAPA via patient sampling
- Keywords
- Influenza, Intensive Care Unit, Influenza-associated pulmonary aspergillose, Invasive Pulmonary Aspergillosis, Virus Diseases, Respiratory tract infections, Fungal Lung Diseases
- Medical subject headings
- Pulmonary Aspergillosis, Influenza, Human, Invasive Pulmonary Aspergillosis, Virus Diseases, Respiratory Tract Infections, Lung Diseases, Fungal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of biomarkers for IAPA via patient samplingOther
Blood, BAL, microbiome
| Study group | Role | What they receive |
|---|---|---|
| IAPA+ | Influenza patients who develop IAPA during ICU admission Receives: Other: Identification of biomarkers for IAPA via patient sampling | |
| IAPA- | Influenza patients admitted to the ICU not developing IAPA Receives: Other: Identification of biomarkers for IAPA via patient sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of IAPA-infection at ICU discharge
The diagnosis of IAPA will be made by the treating physician, according to a strict case definition.
Measured: from date of admission in ICU assessed up to ICU discharge, approximately 21 days
Secondary outcomes (7)
Time to IAPA diagnosis
The diagnosis of IAPA will be made by the treating physician, according to a strict case definition.
Measured: from date of admission in ICU assessed up to ICU discharge, approximately 21 days
Length of ICU stay
Measured: from date of admission in ICU assessed up to ICU discharge, approximately 21 days
Length of hospital stay
Measured: from date of admission in hospital assessed up to hospital discharge, approximately 30 days
ICU mortality
Measured: up to ICU discharge, approximately 21 days
Hospital mortality
Measured: from date of admission in hospital assessed up to hospital discharge, approximately 30 days
30-day mortality
Measured: 30 days
90-day mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start10 Mar 2022
- Primary completion18 May 2026
- Study completion18 May 2026
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 Radboud University Medical CenterThe 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
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joost Wauters, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530799
- Sponsor's protocol ID
- IAPAFLU
- Acronym
- IAPAFLU
- Status last verified
- Jun 2026
- First submitted
- 20 Aug 2020
- Last updated
- 18 Jun 2026
- 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza-associated Pulmonary Aspergillosis (IAPA) in ICU Patients With Severe Influenza: Incidence and Host- and Pathogen Related Risk Factors
- ClinicalTrials.gov ID
- NCT04530799
- Acronym / sponsor ID
- IAPAFLU / IAPAFLU
- Conditions
- Influenza With Pneumonia, Pulmonary Aspergillosis
- Keywords
- Influenza, Intensive Care Unit, Influenza-associated pulmonary aspergillose, Invasive Pulmonary Aspergillosis, Virus Diseases, Respiratory tract infections, Fungal Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 28 Aug 2020 (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.
A prospective multi-center observational study to assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients and to identify host- and pathogen related risk factors for IAPA in EORTC negative ICU patients with severe influenza.
Detailed description
Invasive pulmonary aspergillosis was shown to be a complication of severe influenza infections in immunocompromised patients as well as in immunocompetent patients and is associated with a high mortality. Antifungal prophylaxis might prevent influenza-associated pulmonary aspergillosis (IAPA) and thus might improve the outcome in patients with severe influenza. However, clinical related risk factors should be identified to assess whether a patient will benefit from antifungal prophylaxis. This prospective multi-center observational study will assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients in 12 ICUs in The Netherlands, Belgium and France over 4 influenza seasons. The secondary objective of this study is to identify host- and pathogen related risk factors for IAPA in EORTC negative ICU patients with severe influenza. Patients aged 18 or older admitted to the intensive care unit (ICU) during the inclusion period due severe influenza without classic risk factors defined by the EORTC will be included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IAPA+ | – | Other: Identification of biomarkers for IAPA via patient samplingInfluenza patients who develop IAPA during ICU admission |
| IAPA- | – | Other: Identification of biomarkers for IAPA via patient samplingInfluenza patients admitted to the ICU not developing IAPA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target patient population is the EORTC-negative population of critically ill influenza patients at ICU. Patient identification will rely on daily review of ICU patients with respiratory virus panels ordered in the previous 24 hours.
Key inclusion criteria (5 listed)
- Patients with a PCR-positive respiratory virus panel (RVP) result for influenza within 96 hours before or 48 hours after ICU admission.
- Patients who require ICU admission for more than 24 hours for severe influenza.
- Patients who have respiratory distress (respiratory rate >= 25x/minute and paO2/fiO2 < 300 with or without bilateral infiltrates) as the main reason for ICU admission.
- Patients who do not have an EORTC host factor.
- Patients who are at least 18 years of age.
Key exclusion criteria (4 listed)
- Patients with age < 18 years as extensive sampling is required
- Expected survival on ICU admission ≤ 48h
- Patients that are being treated actively with antifungal agents for invasive aspergillosis.
- Patients or their legal representatives who did not sign the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification of biomarkers for IAPA via patient samplingBlood, BAL, microbiome | Other | IAPA+, IAPA- |
Primary outcome
The incidence of IAPA-infection at ICU discharge
Time frame: from date of admission in ICU assessed up to ICU discharge, approximately 21 days
The diagnosis of IAPA will be made by the treating physician, according to a strict case definition.
7 secondary outcomes
Time to IAPA diagnosis
Time frame: from date of admission in ICU assessed up to ICU discharge, approximately 21 days
Length of ICU stay
Time frame: from date of admission in ICU assessed up to ICU discharge, approximately 21 days
Length of hospital stay
Time frame: from date of admission in hospital assessed up to hospital discharge, approximately 30 days
ICU mortality
Time frame: up to ICU discharge, approximately 21 days
Hospital mortality
Time frame: from date of admission in hospital assessed up to hospital discharge, approximately 30 days
30-day mortality
Time frame: 30 days
90-day mortality
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- 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. This study is not recruiting at the moment.
Joost Wauters, MD, PhD principal investigator
UZ Leuven
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza With Pneumonia and Pulmonary Aspergillosis, run by Radboud University Medical Center at 12 sites in 3 countries.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, Belgium, Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of IAPA-infection at ICU discharge (time frame: from date of admission in ICU assessed up to ICU discharge, approximately 21 days). 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 18 Jun 2026.