Invasive Pulmonary Aspergillosis Complicating Influenza Infection
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|ClinicalTrials.gov Identifier: NCT03391492|
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : April 20, 2018
|Condition or disease|
|Influenza With Pneumonia Aspergillosis Invasive|
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|
|Estimated Enrollment :||100 participants|
|Official Title:||Invasive Pulmonary Aspergillosis Complicating Influenza Infection in Critically Ill Patients: a Prospective, Observational, Multicenter Case Control Registration Study|
|Actual Study Start Date :||January 20, 2018|
|Estimated Primary Completion Date :||March 30, 2020|
|Estimated Study Completion Date :||May 30, 2020|
All consecutive patients older than 18 years ,admitted to the ICU with respiratory distress with microbiologically confirmed diagnosis of influenza
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,
- incidence IPA between ICU patients with severe influenza and in influenza-negative control patients [ Time Frame: 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
- 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.
- variations in baseline factors and risk factors between influenza and non-influenza patients in ICU [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391492
|Contact: Joost Wauters, Phdfirstname.lastname@example.org|
|AZ sint Jan||Recruiting|
|Brugge, Belgium, 8000|
|Contact: Marc Bourgeois, PhD|
|Contact: Joke Denolf, SC|
|Hasselt, Belgium, 3500|
|Contact: Petere Messiaen, Phd|
|Principal Investigator:||Joost Wauters, Phd||UZ Leuven|