Prevalence of Influenza RelAted Invasive Aspergillosis

Influenza, Human Clinical Trial

— PIRAIA  

Official title:

The Prevalence of Influenza Related Invasive Aspergillosis in Swedish Intensive Care Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04172610
• Other study ID #: K 2019-9546
• Status: Completed
• Start date: December 2, 2019
• Est. completion date: April 14, 2023

Study information

• Verified date: July 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Influenza, Human
• Invasive Pulmonary Aspergillosis
• Pulmonary Aspergillosis

Locations

Country	Name	City	State
Sweden	ICU at Mälarsjukhuset	Eskilstuna
Sweden	ICU at Helsingborgs lasarett	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

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Official Study Website