Clinical trial NCT03391492: Invasive Pulmonary Aspergillosis Complicating Influenza Infection
Official title: Invasive Pulmonary Aspergillosis Complicating Influenza Infection in Critically Ill Patients: a Prospective, Observational, Multicenter Case Control Registration Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza With Pneumonia
Aspergillosis Invasive
Keywords: ICU
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients admitted from home to ICU with respiratory distress, with documented pulmonary infiltrates and initiation of antimicrobial therapy because community acquired pneumonia is the primary diagnosis or in the differential diagnosis.

Confirmation of presence or absence of influenza is based on probe-based reverse-transcriptase polymerase chain reaction (RT-PCR) for influenza A or B directly on sputum, bronchial aspirate, broncho-alveolar (BAL) fluid or a nasopharyngeal swab.

Brief summary: Study the incidence and outcome of invasive pulmonary aspergillosis (IPA) in ICU patients with severe influenza and in influenza-negative control patients with severe community-acquired pneumonia

Detailed description: This prospective multicentre case-control registration study in Dutch and Belgian ICUs will assess the difference in incidence and outcome of invasive pulmonary aspergillosis (IPA) in ICU patients with severe influenza compared with influenza-negative control patients with severe community-acquired pneumonia during the coming three influenza seasons (2017-2020). The study will further assess the differences in clinical characteristics and risk factors between influenza patients with and without invasive aspergillosis.

All consecutive patients aged 18 or older admitted to ICU during the inclusion period with respiratory distress due to influenza positive/negative community acquired pneumonia (CAP) will be included.

Eligibility criteria: Inclusion Criteria:

* patient older than 18 years,admitted to ICU with respiratory distress with microbiologically confirmed diagnosis of influenza (for inclusion in the influenza group)
* patients older than 18 years, admitted to ICU for respiratory distress due to community-acquired pneumonia , with a microbiologically confirmed absence of influenza (for inclusion in the control group)

Exclusion Criteria:

* age \< 18 year
* no informed consent

Primary outcomes:
measure: incidence IPA between ICU patients with severe influenza and in influenza-negative control patients
timeFrame: from date of admission in ICU assessed up to ICU discharge, approximately 21 days
Secondary outcomes:
measure: variations in baseline factors and risk factors between influenza and non-influenza patients in ICU
timeFrame: from date of admission in ICU to date of ICU discharge, approximately 21 days
measure: rate of IPA disease progression
timeFrame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
measure: rate of presence of azole resistance
timeFrame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ sint Jan
city: Hasselt
country: Belgium
facility: Jessa AH
Study officials:
affiliation: UZ Leuven
name: Joost Wauters, Phd
role: PRINCIPAL_INVESTIGATOR
References: