Prevalence of Influenza RelAted Invasive Aspergillosis

Study Overview
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Brief Summary
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This is a multicenter study with the aim to determine the prevalence of influenza-related invasive pulmonary aspergillosis in Swedish intensive care units and to assess the clinical impact of and risk factors for influenza-related invasive pulmonary aspergillosis

Detailed Description
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This is a multicenter prospective observational study conducted at 12 intensive care units (ICU) in Sweden. All patients >18 years of age with a Polymerase Chain Reaction (PCR)-verified influenza A or B diagnosed up to 7 days before admission to the ICU or during ICU care, will be included in the study. A new clinical routine has been implemented at the study centers: During the ICU stay screening with Beta-D-glucan and Galactomannan in blood/serum will be performed twice weekly and a respiratory sample will be retrieved for fungal culture and microscopy once weekly. All results from collected samples will be available to the patient's attending physicians. Clinical and microbiological data will be collected, and the diagnosis of invasive aspergillosis will be made using predefined diagnostic criteria. Objectives: To determine the prevalence of influenza-related invasive pulmonary aspergillosis in Swedish intensive care units To assess the clinical impact of and risk factors for influenza-related invasive pulmonary aspergillosis

Official Title
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The Prevalence of Influenza Related Invasive Aspergillosis in Swedish Intensive Care Units

Conditions
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Invasive Pulmonary Aspergillosis, Influenza, Human

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed influenza A or B diagnosed up to 7 days before ICU admission, or during ICU care Admitted to the ICU Exclusion Criteria: - Under 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of proven or probable invasive pulmonary aspergillosis | Enrolled patients will be categorized as proven or probable invasive pulmonary aspergillosis at discharge from the ICU. | From date of enrollment up to 90 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequential Organ Failure assessment Score (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | Registered once daily. Range 0-24, a higher score indicates a higher mortality risk | from date of admission to ICU to date of discharge from ICU, approximately 21 days | 
| Use of mechanical ventilation (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | Yes/No. Registered once daily. | from date of admission to ICU to date of discharge from ICU, approximately 21 days | 
| Use of non-invasive ventilation (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | Yes/No. Registered once daily | from date of admission to ICU to date of discharge from ICU, approximately 21 days | 
| Use of vasopressor (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)pulmonary aspergillosis and those that were not) | Yes/No. Registered once daily. | from date of admission to ICU to date of discharge from ICU, approximately 21 days | 
| Use of renal replacement therapy (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | Yes/No. Registered once daily. | from date of admission to ICU to date of discharge from ICU, approximately 21 days | 
| Acute Respiratory Distress Syndrome (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | Registered once daily, using the Berlin-definition (mild 200 mm Hg < PaO2/FIO2 ≤ 300 mm Hg), moderate (100 mm Hg < PaO2/FIO2 ≤ 200 mm Hg), and severe (PaO2/FIO2 ≤ 100 mm Hg) | from date of admission to ICU to date of discharge from ICU, approximately 21 days | 
| Days of ICU stay (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | Median number of days | from date of admission to ICU to date of discharge from ICU, approximately 21 days | 
| ICU mortality (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | Yes/No | from date of admission to ICU to date of discharge from ICU, approximately 21 days | 
| 90-day mortality after ICU admission (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | Yes/No | from date of ICU admission to 90 days after ICU admission |