Prospective Observational Trial of IAPA (IAPAFLU)

Radboud University Medical Center

Status

Enrolling

Conditions

Influenza With Pneumonia

Pulmonary Aspergillosis

Treatments

Other: Identification of biomarkers for IAPA via patient sampling

Study type

Observational

Funder types

Other

Identifiers

NCT04530799

IAPAFLU

Details and patient eligibility

About

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.

Full 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.

Enrollment

350 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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