Influenza, Human, Invasive Pulmonary Aspergillosis
Conditions
Brief summary
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
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: 1. To determine the prevalence of influenza-related invasive pulmonary aspergillosis in Swedish intensive care units 2. To assess the clinical impact of and risk factors for influenza-related invasive pulmonary aspergillosis
Interventions
None listed
Sponsors
Karolinska University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of proven or probable invasive pulmonary aspergillosis | From date of enrollment up to 90 days after enrollment | Enrolled patients will be categorized as proven or probable invasive pulmonary aspergillosis at discharge from the ICU. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of mechanical ventilation (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | from date of admission to ICU to date of discharge from ICU, approximately 21 days | Yes/No. Registered once daily. |
| Use of non-invasive ventilation (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | from date of admission to ICU to date of discharge from ICU, approximately 21 days | Yes/No. Registered once daily |
| Use of vasopressor (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)pulmonary aspergillosis and those that were not) | from date of admission to ICU to date of discharge from ICU, approximately 21 days | Yes/No. Registered once daily. |
| Use of renal replacement therapy (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | from date of admission to ICU to date of discharge from ICU, approximately 21 days | Yes/No. Registered once daily. |
| Sequential Organ Failure assessment Score (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | from date of admission to ICU to date of discharge from ICU, approximately 21 days | Registered once daily. Range 0-24, a higher score indicates a higher mortality risk |
| Days of ICU stay (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | from date of admission to ICU to date of discharge from ICU, approximately 21 days | Median number of days |
| ICU mortality (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | from date of admission to ICU to date of discharge from ICU, approximately 21 days | Yes/No |
| 90-day mortality after ICU admission (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | from date of ICU admission to 90 days after ICU admission | Yes/No |
| Acute Respiratory Distress Syndrome (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not) | from date of admission to ICU to date of discharge from ICU, approximately 21 days | 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) |
Countries
Sweden
Outcome results
None listed