Prevalence of Influenza RelAted Invasive Aspergillosis

Completed

• Conditions: Influenza, Human; Invasive Pulmonary Aspergillosis

• Registration Number: NCT04172610
• Lead Sponsor: Karolinska University Hospital

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

Study Timeline

• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-21
• Study Start: 2019-12-02
• Primary Completion: 2023-04-14
• Study Completion: 2023-04-14
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-05
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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.
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)
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

Trial Locations

Locations (10)

ICU at Mälarsjukhuset; 🇸🇪 Eskilstuna, Sweden

ICU at Karolinska Universitetssjukhuset Solna; 🇸🇪 Stockholm, Sweden

ICU at Danderyds sjukhus; 🇸🇪 Stockholm, Sweden

ICU at Akademiska sjukhuset; 🇸🇪 Uppsala, Sweden

ICU at Västmanlands sjukhus; 🇸🇪 Västerås, Sweden

ICU at Länssjukhuset Ryhov; 🇸🇪 Jönköping, Sweden

ICU at Universitetssjukhuset; 🇸🇪 Örebro, Sweden

ICU at Helsingborgs lasarett; 🇸🇪 Helsingborg, Sweden

ICU at Karolinska Universitetssjukhuset Huddinge; 🇸🇪 Stockholm, Sweden

ICU at Skånes universitetssjukhus; 🇸🇪 Malmö, Sweden