Invasive Pulmonary Aspergillosis Complicating Influenza Infection

Aspergillosis Invasive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391492
• Other study ID #: Basilicum
• Status: Completed
• Start date: January 20, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Aspergillosis Invasive
• Influenza With Pneumonia
• Influenza, Human
• Invasive Pulmonary Aspergillosis
• Pulmonary Aspergillosis

Locations

Country	Name	City	State
Belgium	AZ sint Jan	Brugge
Belgium	Jessa AH	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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