Aspergillosis Invasive, Influenza With Pneumonia
Conditions
Keywords
ICU
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.
Interventions
None listed
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence IPA between ICU patients with severe influenza and in influenza-negative control patients | from date of admission in ICU assessed up to ICU discharge, approximately 21 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| variations in baseline factors and risk factors between influenza and non-influenza patients in ICU | from date of admission in ICU to date of ICU discharge, approximately 21 days | difference in baseline factors: demographic, biochemical, microbiological and radiological data |
| rate of IPA disease progression | from date of admission to ICU to date of discharge from ICU, approximately 21 days | rate of IPA disease progression in the subgroup of patients with IPA |
| rate of presence of azole resistance | from date of admission to ICU to date of discharge from ICU, approximately 21 days | rate of presence of azole resistance in the subgroup of patients with IPA |
Countries
Belgium
Outcome results
None listed