Aspergillosis in patients with severe influenza (AspiFlu)
Research type
Research Study
Full title
Incidence and Pathogenesis of Invasive Aspergillosis in Intensive Care Patients with Severe Influenza (AspiFLu)
IRAS ID
271269
Contact name
Tihana Bicanic
Contact email
Sponsor organisation
Joint Research and Enterprise Services (JRES)
Duration of Study in the UK
0 years, 9 months, 5 days
Research summary
Some patients with Influenza (‘flu’) develop severe infection requiring admission to intensive care. Recent research suggests that patients with severe influenza may be susceptible to a second infection with a type of fungus called Aspergillus.\n\nInvasive aspergillosis (IA) carries a high mortality but there are potentially life-saving treatments. Unfortunately, IA may be under-diagnosed currently in patients with influenza.\n\nThis study will take place across three London teaching hospitals during the 2019/2020 influenza season. It will enrol ventilated adults admitted to intensive care with severe influenza.\n\nThe main objective of the study is to assess what proportion of critically ill patients with severe influenza develop IA, and what factors increase the risk of this happening. We will also look at whether those that do develop IA are more likely to have a prolonged ICU admission or die.\n\nThis study could help to raise awareness of the potentially high incidence of IA in patients with severe influenza supporting the development of guidance ensuring that appropriate diagnostics are performed in these patients. \n\nBronchoscopy is a procedure whereby a small camera is used to look inside the lungs. Fluid can then be squirted and re-collected to diagnose the cause of the infection (a bronchoalveolar lavage, BAL). Tests performed on BAL fluid can help diagnose IA but are not available at all hospitals. This study will store surplus BAL samples from patients, and later use them to evaluate a new test called the Aspergillus Lateral Flow Device.\n\nSurplus BAL, and blood samples from patients will also be stored and used at a later date to study why patients with influenza develop COVID-19 amendment 18/03/2020 This is a COVID-19 related amendment for expedite review: This substantial amendment concerns a proposed change to our inclusion criteria to include patients with severe COVID-19 to act as a comparison group for patients with influenza. Summary of changes: • Inclusion criteria has been changed to: Intubated adults admitted to intensive care (ICU) with severe influenza or COVID-19. • A new secondary outcome measure has been introduced: Compare the incidence of IA in critically ill patients with influenza to that of a comparison group with COVID-19. • Intervention for the COVID-19 group will the same as for influenza: o Blood draw and storage of additional 7.5ml-40ml blood volume at enrolment for sub-studies. o Surplus BAL sample from bronchoscopy performed as part of routine clinical care will be saved for subsequent analysis. • We will aim to recruit similar number of COVID19 patients in order to approach an ideal target 1:1 ratio of patients with influenza and COVID19. • The incidence of IA (including proven and putative) will be compared between patients with influenza, and with COVID-19 infection. The risk of IA will be compared between the 2 groups using multivariable logistic regression.
REC name
Wales REC 5
REC reference
19/WA/0310
Date of REC Opinion
24 Oct 2019
REC opinion
Favourable Opinion