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Completed

NCT Number: NCT04530799

Prospective Observational Trial of IAPA

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Identification of biomarkers for IAPA via patient sampling

Other

Blood, BAL, microbiome

Primary outcomes

  1. The incidence of IAPA-infection at ICU discharge

    Time frame: from date of admission in ICU assessed up to ICU discharge, approximately 21 days

    The diagnosis of IAPA will be made by the treating physician, according to a strict case definition.

Secondary outcomes

  1. Time to IAPA diagnosis

    Time frame: from date of admission in ICU assessed up to ICU discharge, approximately 21 days

    The diagnosis of IAPA will be made by the treating physician, according to a strict case definition.

  2. Length of ICU stay

    Time frame: from date of admission in ICU assessed up to ICU discharge, approximately 21 days

  3. Length of hospital stay

    Time frame: from date of admission in hospital assessed up to hospital discharge, approximately 30 days

  4. ICU mortality

    Time frame: up to ICU discharge, approximately 21 days

  5. Hospital mortality

    Time frame: from date of admission in hospital assessed up to hospital discharge, approximately 30 days

  6. 30-day mortality

    Time frame: 30 days

  7. 90-day mortality

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Acronym: IAPAFLU

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2020
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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