Prevalence of Influenza RelAted Invasive Aspergillosis

NCT ID: NCT04172610

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-02

Study Completion Date

2023-04-14

Brief Summary

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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

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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

Conditions

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Invasive Pulmonary Aspergillosis Influenza, Human

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anders Krifors

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Krifors, M.D.

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Markus Castegren, M.D. Ph.D.

Role: STUDY_DIRECTOR

Karolinska Institutet

Ola Blennow, M.D. Ph.D.

Role: STUDY_CHAIR

Karolinska Institutet

Johan Petersson, M.D. A/Prof.

Role: STUDY_CHAIR

Karolinska Institutet

Locations

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ICU at Mälarsjukhuset

Eskilstuna, , Sweden

Site Status

ICU at Helsingborgs lasarett

Helsingborg, , Sweden

Site Status

ICU at Länssjukhuset Ryhov

Jönköping, , Sweden

Site Status

ICU at Universitetssjukhuset

Linköping, , Sweden

Site Status

ICU at Skånes universitetssjukhus

Lund, , Sweden

Site Status

ICU at Skånes universitetssjukhus

Malmo, , Sweden

Site Status

ICU at Universitetssjukhuset

Örebro, , Sweden

Site Status

ICU at Danderyds sjukhus

Stockholm, , Sweden

Site Status

ICU at Karolinska Universitetssjukhuset Huddinge

Stockholm, , Sweden

Site Status

ICU at Karolinska Universitetssjukhuset Solna

Stockholm, , Sweden

Site Status

ICU at Akademiska sjukhuset

Uppsala, , Sweden

Site Status

ICU at Västmanlands sjukhus

Västerås, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 37897800 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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K 2019-9546

Identifier Type: -

Identifier Source: org_study_id

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