NCT04530799

Prospective Observational Trial of IAPA

Influenza-associated Pulmonary Aspergillosis (IAPA) in ICU Patients With Severe Influenza: Incidence and Host- and Pathogen Related Risk Factors

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza With Pneumonia
• Pulmonary Aspergillosis

Interventions

Type	Name	Description
OTHER	Identification of biomarkers for IAPA via patient sampling	Blood, BAL, microbiome

Timeline

• Start date: 2022-03-10
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2020-08-28
• Last updated: 2026-04-01

Locations

12 sites across 3 countries: Belgium, France, Netherlands