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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
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:
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Under 18 years of age
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All patients ≥18 years of age with confirmed influenza A or B diagnosed up to 7 days before ICU admission, or during ICU care, will be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Anders Krifors, M.D. | Karolinska Institutet | Principal Investigator |
| Markus Castegren, M.D. Ph.D. | Karolinska Institutet | Study Director |
| Ola Blennow, M.D. Ph.D. | Karolinska Institutet | Study Chair |
| Johan Petersson, M.D. A/Prof. | Karolinska Institutet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICU at Mälarsjukhuset | Eskilstuna | Sweden | ||||
| ICU at Helsingborgs lasarett |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37897800 | Derived | Krifors A, Blennow O, Pahlman LI, Gille-Johnson P, Janols H, Lipcsey M, Kallman J, Tham J, Stjarne Aspelund A, Ljungquist O, Hammarskjold F, Hallgren A, De Geer L, Lemberg M, Petersson J, Castegren M. Influenza-associated invasive aspergillosis in patients admitted to the intensive care unit in Sweden: a prospective multicentre cohort study. Infect Dis (Lond). 2024 Feb;56(2):110-115. doi: 10.1080/23744235.2023.2273381. Epub 2023 Dec 18. |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices)
Beginning 3 months and ending 5 years following article publication
Researchers who provide a methodologically sound proposal
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2019 | Nov 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055744 | Invasive Pulmonary Aspergillosis |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D055732 | Pulmonary Aspergillosis |
| D001228 | Aspergillosis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| 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 |
| Helsingborg |
| Sweden |
| ICU at Länssjukhuset Ryhov | Jönköping | Sweden |
| ICU at Universitetssjukhuset | Linköping | Sweden |
| ICU at Skånes universitetssjukhus | Lund | Sweden |
| ICU at Skånes universitetssjukhus | Malmö | Sweden |
| ICU at Universitetssjukhuset | Örebro | Sweden |
| ICU at Danderyds sjukhus | Stockholm | Sweden |
| ICU at Karolinska Universitetssjukhuset Huddinge | Stockholm | Sweden |
| ICU at Karolinska Universitetssjukhuset Solna | Stockholm | Sweden |
| ICU at Akademiska sjukhuset | Uppsala | Sweden |
| ICU at Västmanlands sjukhus | Västerås | Sweden |
| D007239 |
| Infections |
| D000072742 | Invasive Fungal Infections |
| D008172 | Lung Diseases, Fungal |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012141 | Respiratory Tract Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |