Clinical trial NCT04530799: Prospective Observational Trial of IAPA
Official title: Influenza-associated Pulmonary Aspergillosis (IAPA) in ICU Patients With Severe Influenza: Incidence and Host- and Pathogen Related Risk Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of IAPA-infection at ICU discharge
timeFrame: from date of admission in ICU assessed up to ICU discharge, approximately 21 days
Secondary outcomes:
measure: Time to IAPA diagnosis
timeFrame: from date of admission in ICU assessed up to ICU discharge, approximately 21 days
measure: Length of ICU stay
timeFrame: from date of admission in ICU assessed up to ICU discharge, approximately 21 days
measure: Length of hospital stay
timeFrame: from date of admission in hospital assessed up to hospital discharge, approximately 30 days
measure: ICU mortality
timeFrame: up to ICU discharge, approximately 21 days
measure: Hospital mortality
timeFrame: from date of admission in hospital assessed up to hospital discharge, approximately 30 days
measure: 30-day mortality
timeFrame: 30 days
measure: 90-day mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ St-Jan
city: Leuven
country: Belgium
facility: UZ Leuven
city: Roeselare
country: Belgium
facility: AZ Delta
city: Amiens
country: France
facility: Amiens-Picardie University Hospital
city: Lille
country: France
facility: Centre Hospitalier REgional Universitaire de Lille
city: Paris
country: France
facility: Henri Mondor Hopital
city: Paris
country: France
facility: Hopital Bichat
city: Paris
country: France
facility: Hopital Lariboisiere
city: Rennes
country: France
facility: Hopital Pontchaillou, Centre Hospitalier Universitaire de Rennes
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Amsterdam
country: Netherlands
facility: AmsterdamUMC, locatie VUmc
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
Study officials:
affiliation: UZ Leuven
name: Joost Wauters, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: