Prospective Observational Trial of IAPA

Influenza With Pneumonia Clinical Trial

— IAPAFLU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04530799
• Other study ID #: IAPAFLU
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Aspergillosis
• Influenza With Pneumonia
• Influenza, Human
• Pulmonary Aspergillosis

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