Clinical trial NCT04172610: Prevalence of Influenza RelAted Invasive Aspergillosis
Official title: The Prevalence of Influenza Related Invasive Aspergillosis in Swedish Intensive Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Pulmonary Aspergillosis
Influenza, Human
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of proven or probable invasive pulmonary aspergillosis
timeFrame: From date of enrollment up to 90 days after enrollment
Secondary outcomes:
measure: Sequential Organ Failure assessment Score (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)
timeFrame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
measure: Use of mechanical ventilation (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)
timeFrame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
measure: Use of non-invasive ventilation (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)
timeFrame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
measure: Use of vasopressor (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)pulmonary aspergillosis and those that were not)
timeFrame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
measure: Use of renal replacement therapy (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)
timeFrame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
measure: Acute Respiratory Distress Syndrome (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)
timeFrame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
measure: Days of ICU stay (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)
timeFrame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
measure: ICU mortality (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)
timeFrame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
measure: 90-day mortality after ICU admission (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)
timeFrame: from date of ICU admission to 90 days after ICU admission
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: ICU at Mälarsjukhuset
city: Helsingborg
country: Sweden
facility: ICU at Helsingborgs lasarett
city: Jönköping
country: Sweden
facility: ICU at Länssjukhuset Ryhov
city: Linköping
country: Sweden
facility: ICU at Universitetssjukhuset
city: Lund
country: Sweden
facility: ICU at Skånes universitetssjukhus
city: Malmö
country: Sweden
facility: ICU at Skånes universitetssjukhus
city: Stockholm
country: Sweden
facility: ICU at Danderyds sjukhus
city: Stockholm
country: Sweden
facility: ICU at Karolinska Universitetssjukhuset Huddinge
city: Stockholm
country: Sweden
facility: ICU at Karolinska Universitetssjukhuset Solna
city: Uppsala
country: Sweden
facility: ICU at Akademiska sjukhuset
city: Västerås
country: Sweden
facility: ICU at Västmanlands sjukhus
city: Örebro
country: Sweden
facility: ICU at Universitetssjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Anders Krifors, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Markus Castegren, M.D. Ph.D.
role: STUDY_DIRECTOR
affiliation: Karolinska Institutet
name: Ola Blennow, M.D. Ph.D.
role: STUDY_CHAIR
affiliation: Karolinska Institutet
name: Johan Petersson, M.D. A/Prof.
role: STUDY_CHAIR
References: