NCT04530799

Brief 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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
3 countries

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

August 20, 2020

Last Update Submit

March 31, 2026

Conditions

Influenza With PneumoniaPulmonary Aspergillosis

Keywords

InfluenzaIntensive Care UnitInfluenza-associated pulmonary aspergilloseInvasive Pulmonary AspergillosisVirus DiseasesRespiratory tract infectionsFungal Lung Diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

    from date of admission in ICU assessed up to ICU discharge, approximately 21 days

Secondary Outcomes (7)

  • Time to IAPA diagnosis

    from date of admission in ICU assessed up to ICU discharge, approximately 21 days

  • Length of ICU stay

    from date of admission in ICU assessed up to ICU discharge, approximately 21 days

  • Length of hospital stay

    from date of admission in hospital assessed up to hospital discharge, approximately 30 days

  • ICU mortality

    up to ICU discharge, approximately 21 days

  • Hospital mortality

    from date of admission in hospital assessed up to hospital discharge, approximately 30 days

  • +2 more secondary outcomes

Study Arms (2)

IAPA+

Influenza patients who develop IAPA during ICU admission

Other: Identification of biomarkers for IAPA via patient sampling

IAPA-

Influenza patients admitted to the ICU not developing IAPA

Other: Identification of biomarkers for IAPA via patient sampling

Interventions

Identification of biomarkers for IAPA via patient samplingOTHER

Blood, BAL, microbiome

IAPA+IAPA-

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

AZ St-Jan

Bruges, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

AZ Delta

Roeselare, Belgium

Location

Amiens-Picardie University Hospital

Amiens, 80054, France

Location

Centre Hospitalier REgional Universitaire de Lille

Lille, France

Location

Henri Mondor Hopital

Paris, France

Location

Hopital Bichat

Paris, France

Location

Hopital Lariboisiere

Paris, France

Location

Hopital Pontchaillou, Centre Hospitalier Universitaire de Rennes

Rennes, France

Location

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, Provincie Groningen, 9713, Netherlands

Location

AmsterdamUMC, locatie VUmc

Amsterdam, 1081, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA

MeSH Terms

Conditions

Pulmonary AspergillosisInfluenza, HumanInvasive Pulmonary AspergillosisVirus DiseasesRespiratory Tract InfectionsLung Diseases, Fungal

Condition Hierarchy (Ancestors)

AspergillosisMycosesBacterial Infections and MycosesInfectionsLung DiseasesRespiratory Tract DiseasesOrthomyxoviridae InfectionsRNA Virus InfectionsInvasive Fungal Infections

Study Officials

  • Joost Wauters, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2020

First Posted

August 28, 2020

Study Start

March 10, 2022

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations

NL(3)FR(6)BE(3)