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NCT Number: NCT03391492

Invasive Pulmonary Aspergillosis Complicating Influenza Infection

Study the incidence and outcome of invasive pulmonary aspergillosis (IPA) in ICU patients with severe influenza and in influenza-negative control patients with severe community-acquired pneumonia

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Key information

Conditions

Influenza With Pneumonia Aspergillosis Invasive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ sint Jan, Bruges, Belgium

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About this study

This prospective multicentre case-control registration study in Dutch and Belgian ICUs will assess the difference in incidence and outcome of invasive pulmonary aspergillosis (IPA) in ICU patients with severe influenza compared with influenza-negative control patients with severe community-acquired pneumonia during the coming three influenza seasons (2017-2020). The study will further assess the differences in clinical characteristics and risk factors between influenza patients with and without invasive aspergillosis.

All consecutive patients aged 18 or older admitted to ICU during the inclusion period with respiratory distress due to influenza positive/negative community acquired pneumonia (CAP) will be included.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient older than 18 years,admitted to ICU with respiratory distress with microbiologically confirmed diagnosis of influenza (for inclusion in the influenza group)
  • patients older than 18 years, admitted to ICU for respiratory distress due to community-acquired pneumonia , with a microbiologically confirmed absence of influenza (for inclusion in the control group)

Exclusion criteria

  • age < 18 year
  • no informed consent

Treatment and study plan

Primary outcomes

  1. incidence IPA between ICU patients with severe influenza and in influenza-negative control patients

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

    incidence of mycological evidence of Aspergillus and at least one Aspergillus compatible sign or symptom and radiological abnormalities based on Chest CT or Chest X ray. Mycological evidence can be provided by either (A) a positive culture of Aspergillus cultured from bronchoalveolar lavage (BAL) sample, (B) ≥2 positive cultures of Aspergillus cultured from a sputum or a bronchial aspirate or (C) a galactomannan (GM) optical density of ≥1 in BAL or ≥0.5 in serum. Aspergillus compatible signs or symptoms are defined as at least one of the following:

    • Worsening respiratory insufficiency in spite of proper antibiotic and ventilator support
    • Dyspnea
    • Haemoptysis
    • Fever refractory to at least 3 days of appropriate antibiotic (AB) therapy. Recrudescent fever after a period of defervescence of at least 48 h while still on AB without apparent cause.

    The presence of hyphae in lung biopsy or autopsy are also considered as sufficient evidence for IPA.

Secondary outcomes

  1. variations in baseline factors and risk factors between influenza and non-influenza patients in ICU

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

    difference in baseline factors: demographic, biochemical, microbiological and radiological data

  2. rate of IPA disease progression

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

    rate of IPA disease progression in the subgroup of patients with IPA

  3. rate of presence of azole resistance

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

    rate of presence of azole resistance in the subgroup of patients with IPA

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Invasive Pulmonary Aspergillosis Complicating Influenza Infection in Critically Ill Patients: a Prospective, Observational, Multicenter Case Control Registration Study

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2018
Registry last updated
Jul 30, 2021

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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