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Prospective Observational Trial of IAPA

NCT ID: NCT04530799

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-10

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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Influenza With Pneumonia Pulmonary Aspergillosis

Keywords

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Influenza Intensive Care Unit Influenza-associated pulmonary aspergillose Invasive Pulmonary Aspergillosis Virus Diseases Respiratory tract infections Fungal Lung Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IAPA+

Influenza patients who develop IAPA during ICU admission

Identification of biomarkers for IAPA via patient sampling

Intervention Type OTHER

Blood, BAL, microbiome

IAPA-

Influenza patients admitted to the ICU not developing IAPA

Identification of biomarkers for IAPA via patient sampling

Intervention Type OTHER

Blood, BAL, microbiome

Interventions

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Identification of biomarkers for IAPA via patient sampling

Blood, BAL, microbiome

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joost Wauters, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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AZ St-Jan

Bruges, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

AZ Delta

Roeselare, , Belgium

Site Status RECRUITING

Amiens-Picardie University Hospital

Amiens, , France

Site Status RECRUITING

Centre Hospitalier REgional Universitaire de Lille

Lille, , France

Site Status RECRUITING

Henri Mondor Hopital

Paris, , France

Site Status RECRUITING

Hopital Bichat

Paris, , France

Site Status RECRUITING

Hopital Lariboisiere

Paris, , France

Site Status RECRUITING

Hopital Pontchaillou, Centre Hospitalier Universitaire de Rennes

Rennes, , France

Site Status RECRUITING

Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

AmsterdamUMC, locatie VUmc

Amsterdam, , Netherlands

Site Status RECRUITING

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Site Status RECRUITING

Countries

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Belgium France Netherlands

Central Contacts

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Joost Wauters, MD, PhD

Role: CONTACT

Phone: +32-16-344275

Email: [email protected]

Facility Contacts

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M. Bourgeois, MD

Role: primary

J. Wauters, MD

Role: primary

P. Lormans, MD

Role: primary

Rémy Nyga, Dr

Role: primary

N. Saad, MD

Role: primary

A. Mekontso Dessap, MD

Role: primary

JF Timsit, MD

Role: primary

B. Megarbane, MD

Role: primary

JM Tadie, MD

Role: primary

Frank vd Veerdonk, Prof. Dr.

Role: primary

K van Dijk, MD

Role: primary

C. van den Berg, MD

Role: primary

Other Identifiers

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IAPAFLU

Identifier Type: -

Identifier Source: org_study_id