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Invasive Pulmonary AspergillosisPIRAIANCT04172610

Prevalence of Influenza RelAted Invasive Aspergillosis

An observational study of Invasive Pulmonary Aspergillosis and Influenza, Human, run by Karolinska University Hospital at 12 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
How many people
55 participants
Where
12 sitesSweden
Study dates
2 Dec 2019to 14 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Confirmed influenza A or B diagnosed up to 7 days before ICU admission, or during ICU care
  • Admitted to the ICU

Who cannot join

  • Under 18 years of age

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Sweden12 sites

  • ICU at Mälarsjukhuset

    Eskilstuna

  • ICU at Helsingborgs lasarett

    Helsingborg

  • ICU at Länssjukhuset Ryhov

    Jönköping

  • ICU at Universitetssjukhuset

    Linköping

  • ICU at Skånes universitetssjukhus

    Lund

  • ICU at Skånes universitetssjukhus

    Malmö

  • ICU at Universitetssjukhuset

    Örebro

  • ICU at Danderyds sjukhus

    Stockholm

  • ICU at Karolinska Universitetssjukhuset Huddinge

    Stockholm

  • ICU at Karolinska Universitetssjukhuset Solna

    Stockholm

  • ICU at Akademiska sjukhuset

    Uppsala

  • ICU at Västmanlands sjukhus

    Västerås

Other trials in Sweden

About this study

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

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

Read the 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
Medical subject headings
Invasive Pulmonary Aspergillosis, Influenza, Human

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From date of enrollment up to 90 days after enrollment

Secondary outcomes (9)

  1. 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

    Measured: from date of admission to ICU to date of discharge from ICU, approximately 21 days

  2. Use of mechanical ventilation (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)

    Yes/No. Registered once daily.

    Measured: from date of admission to ICU to date of discharge from ICU, approximately 21 days

  3. Use of non-invasive ventilation (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)

    Yes/No. Registered once daily

    Measured: from date of admission to ICU to date of discharge from ICU, approximately 21 days

  4. 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.

    Measured: from date of admission to ICU to date of discharge from ICU, approximately 21 days

  5. Use of renal replacement therapy (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)

    Yes/No. Registered once daily.

    Measured: from date of admission to ICU to date of discharge from ICU, approximately 21 days

  6. 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)

    Measured: from date of admission to ICU to date of discharge from ICU, approximately 21 days

  7. Days of ICU stay (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)

    Median number of days

    Measured: from date of admission to ICU to date of discharge from ICU, approximately 21 days

  8. ICU mortality (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)

    Yes/No

    Measured: from date of admission to ICU to date of discharge from ICU, approximately 21 days

  9. 90-day mortality after ICU admission (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)

    Yes/No

    Measured: from date of ICU admission to 90 days after ICU admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2019
  2. Study start2 Dec 2019
  3. Primary completion14 Apr 2023
  4. Study completion14 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04172610
Sponsor's protocol ID
K 2019-9546
Acronym
PIRAIA
Status last verified
Jul 2023
First submitted
11 Nov 2019
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices)

Publications

  • 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.

    PubMed 37897800

Questions about this trial

What is this clinical trial studying?

An observational study of Invasive Pulmonary Aspergillosis and Influenza, Human, run by Karolinska University Hospital at 12 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of proven or probable invasive pulmonary aspergillosis (time frame: From date of enrollment up to 90 days after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04172610, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.

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