Prospective Observational Trial of IAPA

Radboud University Medical Center350 enrolled

Overview

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.

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

350

Conditions

Influenza With Pneumonia Pulmonary Aspergillosis

Interventions

Identification of biomarkers for IAPA via patient samplingOTHER

Blood, BAL, microbiome

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

AZ St-Jan

Bruges, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Time to IAPA diagnosis

The diagnosis of IAPA will be made by the treating physician, according to a strict case definition.

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

Central Contacts

Joost Wauters, MD, PhD

CONTACT

+32-16-344275 joost.wauters@uzleuven.be

Data from ClinicalTrials.gov

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