Prospective Observational Trial of IAPA

Recruiting

Interventions: Other: Identification of biomarkers for IAPA via patient sampling

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
IAPA+	Identification of biomarkers for IAPA via patient sampling	Influenza patients who develop IAPA during ICU admission
IAPA-	Identification of biomarkers for IAPA via patient sampling	Influenza patients admitted to the ICU not developing IAPA

Primary Outcome Measures

Name	Time	Method
The incidence of IAPA-infection at ICU discharge	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.

Secondary Outcome Measures

Name	Time	Method
30-day mortality	30 days
Time to IAPA diagnosis	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.
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
90-day mortality	90 days

Locations (12): Amiens-Picardie University Hospital
🇫🇷
Amiens, France
AZ St-Jan
🇧🇪
Brugge, Belgium
UZ Leuven
🇧🇪
Leuven, Belgium
AZ Delta
🇧🇪
Roeselare, Belgium
Centre Hospitalier REgional Universitaire de Lille
🇫🇷
Lille, France
Henri Mondor Hopital
🇫🇷
Paris, France
Hopital Bichat
🇫🇷
Paris, France
Hopital Lariboisiere
🇫🇷
Paris, France
Hopital Pontchaillou, Centre Hospitalier Universitaire de Rennes
🇫🇷
Rennes, France
Radboudumc
🇳🇱
Nijmegen, Gelderland, Netherlands
AmsterdamUMC, locatie VUmc
🇳🇱
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱
Groningen, Netherlands