NCT Number: NCT04172610
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
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Notify Me18 year and older
All sexes
Observational
ICU at Mälarsjukhuset, Eskilstuna, Sweden
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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
Time frame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
Yes/No. Registered once daily.
Time frame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
Yes/No. Registered once daily
Time frame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
Yes/No. Registered once daily.
Time frame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
Yes/No. Registered once daily.
Time frame: 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)
Time frame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
Median number of days
Time frame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
Yes/No
Time frame: from date of ICU admission to 90 days after ICU admission
Yes/No
Karolinska University Hospital
Other
The Prevalence of Influenza Related Invasive Aspergillosis in Swedish Intensive Care Units
Acronym: PIRAIA
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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