Invasive Pulmonary Aspergillosis Complicating Influenza Infection

Invasive Pulmonary Aspergillosis Complicating Influenza Infection in Critically Ill Patients: a Prospective, Observational, Multicenter Case Control Registration Study

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

Study Overview

• Status: Completed
• Conditions: Influenza With Pneumonia; Aspergillosis Invasive

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.

• Study Type: Observational
• Enrollment (Actual): 298

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • AZ Sint Jan
  • Hasselt, Belgium, 3500
    • Jessa AH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
influenza group; All consecutive patients older than 18 years ,admitted to the ICU with respiratory distress with microbiologically confirmed diagnosis of influenza
control group; All consecutive patients older than 18 years, admitted to the ICU for respiratory distress due to community-acquired pneumonia (CAP) and with a microbiologically confirmed absence of influenza,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence IPA between ICU patients with severe influenza and in influenza-negative control patients	incidence of mycological evidence of Aspergillus and at least one Aspergillus compatible sign or symptom and radiological abnormalities based on Chest CT or Chest X ray. Mycological evidence can be provided by either (A) a positive culture of Aspergillus cultured from bronchoalveolar lavage (BAL) sample, (B) ≥2 positive cultures of Aspergillus cultured from a sputum or a bronchial aspirate or (C) a galactomannan (GM) optical density of ≥1 in BAL or ≥0.5 in serum. Aspergillus compatible signs or symptoms are defined as at least one of the following: Worsening respiratory insufficiency in spite of proper antibiotic and ventilator support; Dyspnea; Haemoptysis; Fever refractory to at least 3 days of appropriate antibiotic (AB) therapy. Recrudescent fever after a period of defervescence of at least 48 h while still on AB without apparent cause. The presence of hyphae in lung biopsy or autopsy are also considered as sufficient evidence for IPA.	from date of admission in ICU assessed up to ICU discharge, approximately 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
variations in baseline factors and risk factors between influenza and non-influenza patients in ICU	difference in baseline factors: demographic, biochemical, microbiological and radiological data	from date of admission in ICU to date of ICU discharge, approximately 21 days
rate of IPA disease progression	rate of IPA disease progression in the subgroup of patients with IPA	from date of admission to ICU to date of discharge from ICU, approximately 21 days
rate of presence of azole resistance	rate of presence of azole resistance in the subgroup of patients with IPA	from date of admission to ICU to date of discharge from ICU, approximately 21 days

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2018
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): June 30, 2021

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (ACTUAL): January 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: ICU
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Orthomyxoviridae Infections; Lung Diseases, Fungal; Influenza, Human; Aspergillosis; Pulmonary Aspergillosis; Invasive Pulmonary Aspergillosis
• Other Study ID Numbers: Basilicum

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No