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Recruiting NCT03748069

Influenza Associated Aspergillosis In-depth Investigation

— Observational Influenza With Pneumonia Invasive Pulmonary Aspergillosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Influenza With Pneumonia, Invasive Pulmonary Aspergillosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Unraveling the Pathogenesis of Influenza-associated Aspergillosis: a Single-center, Prospective Cohort Pilot Study

Overview

This trial is aimed to study the immunological and pathological characteristics of influenza versus non-influenza severe community-acquired pneumonia patients in ICU.

Detailed description

This trial is aimed to study the immunological and pathological characteristics of influenza versus non-influenza severe community-acquired pneumonia patients in ICU, and correlate findings with occurrence of secondary invasive pulmonary aspergillosis infection.

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.

Primary outcome measures

  • Difference in immune cell profile in blood between influenza and non-influenza CAPIV patients at ICU. [Time frame: through study completion, after 3 influenza seasons (3 years)]
  • Difference in cytokine production of mononuclear cells to fungal stimulation in blood between influenza and non-influenza CAPIV patients at ICU. [Time frame: through study completion, after 3 influenza seasons (3 years)]
  • Difference in function of blood neutrophils between influenza and non-influenza CAPIV patients at ICU. [Time frame: through study completion, after 3 influenza seasons (3 years)]
  • Difference in in immune cell profile in BAL fluid between influenza and non-influenza CAPIV patients at ICU. [Time frame: through study completion, after 3 influenza seasons (3 years)]
  • Difference in cytokine production of mononuclear cells to fungal stimulation in BAL fluid between influenza and non-influenza CAPIV patients at ICU. [Time frame: through study completion, after 3 influenza seasons (3 years)]
  • Difference in function of BAL fluid neutrophils between influenza and non-influenza CAPIV patients at ICU. [Time frame: through study completion, after 3 influenza seasons (3 years)]
  • Difference in pathological hallmarks between influenza and non-influenza CAPIV patients at ICU. [Time frame: through study completion, after 3 influenza seasons (3 years)]
Secondary outcome measures (4)
  • Difference in longitudinal alterations in phagocytic cell and mononuclear inflammatory cell subsets in blood and BAL fluid and their response to fungal stimulation between the main study arms. [Time frame: through study completion, after 3 influenza seasons (3 years)]
  • Longitudinal differences in anatomopathological characteristics of the respiratory tract in CAPIV +/- influenza [Time frame: through study completion, after 3 influenza seasons (3 years)]
  • Correlation of findings with invasive pulmonary aspergillosis incidence [Time frame: through study completion, after 3 influenza seasons (3 years)]
  • Correlation of findings with outcome [Time frame: through study completion, after 3 influenza seasons (3 years)]

Eligibility criteria

Inclusion criteria

  • All patients older than 18 years, admitted to ICU with respiratory distress with microbiologically confirmed diagnosis of influenza (for inclusion in the influenza group)
  • All 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 years old
  • Pregnant women
  • No informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Universitaire Ziekenhuizen Leuven — Leuven

Identifiers

NCT: NCT03748069 · PIAS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗