Prospective Observational Trial of IAPA (IAPAFLU)

March 31, 2026 updated by: Radboud University Medical Center

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

350

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
      • Bruges, Belgium
        • AZ St-Jan
      • Leuven, Belgium
        • UZ Leuven
      • Roeselare, Belgium
        • AZ Delta
  • France
      • Amiens, France, 80054
        • Amiens-Picardie University Hospital
      • Lille, France
        • Centre Hospitalier Régional Universitaire de Lille
      • Paris, France
        • Hopital Lariboisiere
      • Paris, France
        • Hôpital Bichat
      • Paris, France
        • Henri Mondor Hopital
      • Rennes, France
        • Hopital Pontchaillou, Centre Hospitalier Universitaire de Rennes
  • Netherlands
      • Amsterdam, Netherlands, 1081
        • AmsterdamUMC, locatie VUmc
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525GA
        • Radboudumc
    • Provincie Groningen
      • Groningen, Provincie Groningen, Netherlands, 9713
        • Universitair Medisch Centrum Groningen

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IAPA+
Influenza patients who develop IAPA during ICU admission
Other: Identification of biomarkers for IAPA via patient sampling
Blood, BAL, microbiome
IAPA-
Influenza patients admitted to the ICU not developing IAPA
Other: Identification of biomarkers for IAPA via patient sampling
Blood, BAL, microbiome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from date of admission in ICU assessed up to ICU discharge, approximately 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day mortality
Time Frame: 30 days
30 days
90-day mortality
Time Frame: 90 days
90 days
Time to IAPA diagnosis
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.
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
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
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
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
from date of admission in hospital assessed up to hospital discharge, approximately 30 days

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Joost Wauters, MD, PhD, UZ 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)

March 10, 2022

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

August 20, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAPAFLU

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.

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