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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04530799
Other study ID # IAPAFLU
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 10, 2022
Est. completion date December 31, 2024

Study information

Verified date June 2023
Source Radboud University Medical Center
Contact Joost Wauters, MD, PhD
Phone +32-16-344275
Email joost.wauters@uzleuven.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 350
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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

Study Design


Intervention

Other:
Identification of biomarkers for IAPA via patient sampling
Blood, BAL, microbiome

Locations

Country Name City State
Belgium AZ St-Jan Brugge
Belgium UZ Leuven Leuven
Belgium AZ Delta Roeselare
France Centre Hospitalier REgional Universitaire de Lille Lille
France Cochin University Hospital Paris
France Henri Mondor Hopital Paris
France Hopital Bichat Paris
France Hopital Lariboisiere Paris
France Hopital Pontchaillou, Centre Hospitalier Universitaire de Rennes Rennes
Netherlands AmsterdamUMC, locatie VUmc Amsterdam
Netherlands Universitair Medisch Centrum Groningen Groningen
Netherlands Radboudumc Nijmegen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Radboud University Medical Center

Countries where clinical trial is conducted

Belgium,  France,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. from date of admission in ICU assessed up to ICU discharge, approximately 21 days
Secondary Time to IAPA diagnosis The diagnosis of IAPA will be made by the treating physician, according to a strict case definition. from date of admission in ICU assessed up to ICU discharge, approximately 21 days
Secondary Length of ICU stay from date of admission in ICU assessed up to ICU discharge, approximately 21 days
Secondary Length of hospital stay from date of admission in hospital assessed up to hospital discharge, approximately 30 days
Secondary ICU mortality up to ICU discharge, approximately 21 days
Secondary Hospital mortality from date of admission in hospital assessed up to hospital discharge, approximately 30 days
Secondary 30-day mortality 30 days
Secondary 90-day mortality 90 days
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