Prevalence of Influenza RelAted Invasive Aspergillosis

NCT04172610 | Completed

• 1 other identifier: K 2019-9546
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 12

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

Conditions

Invasive Pulmonary Aspergillosis; Influenza, Human

Outcome Measures

Primary Outcomes (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.

  From date of enrollment up to 90 days after enrollment

Secondary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- Under 18 years of age

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (12)

ICU at Mälarsjukhuset

Eskilstuna, Sweden

Location

ICU at Helsingborgs lasarett

Helsingborg, Sweden

Location

ICU at Länssjukhuset Ryhov

Jönköping, Sweden

Location

ICU at Universitetssjukhuset

Linköping, Sweden

Location

ICU at Skånes universitetssjukhus

Lund, Sweden

Location

ICU at Skånes universitetssjukhus

Malmo, Sweden

Location

ICU at Universitetssjukhuset

Örebro, Sweden

Location

ICU at Danderyds sjukhus

Stockholm, Sweden

Location

ICU at Karolinska Universitetssjukhuset Huddinge

Stockholm, Sweden

Location

ICU at Karolinska Universitetssjukhuset Solna

Stockholm, Sweden

Location

ICU at Akademiska sjukhuset

Uppsala, Sweden

Location

ICU at Västmanlands sjukhus

Västerås, Sweden

Location

Related Publications (1)

• 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.

  PMID: 37897800 DERIVED

MeSH Terms

Conditions

Invasive Pulmonary Aspergillosis; Influenza, Human

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Lung Diseases, Fungal; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Study Officials

• Anders Krifors, M.D.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Markus Castegren, M.D. Ph.D.

  Karolinska Institutet

  STUDY DIRECTOR

• Ola Blennow, M.D. Ph.D.

  Karolinska Institutet

  STUDY CHAIR

• Johan Petersson, M.D. A/Prof.

  Karolinska Institutet

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 21, 2019
• Study Start: December 2, 2019
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

SE (12)