HAPOSS

• Research type

  Research Study

• Full title

  Hospital Acquired Pneumonia observational Research Study of Sputum

• IRAS ID

  268957

• Contact name

  Dan Wootton

• Contact email

  dwootton@liverpool.ac.uk

• Sponsor organisation

  University of Liverpool

• ISRCTN Number

  ISRCTN20805366

• Duration of Study in the UK

  0 years, 6 months, 28 days

• Research summary

  This is a preliminary study to support a future trial evaluating the effectiveness of a new microbiological test for Hospital Acquired Pneumonia (HAP).

  HAP is a common and serious lung infection that occurs in all hospitals and on all wards. It particularly affects elderly patients. The new test is the BIOFIRE® FILMARRAY® PNEUMONIA PANEL - FAPP for short. The FAPP is approved for use in the EU and USA (CE marked and FDA approved). It detects the bacteria and viruses that cause HAP and genes that indicate resistance to certain antibiotics.

  FAPP can be used outside of a laboratory and requires only brief training and no prior laboratory experience. Results take 75 minutes, which is much quicker than standard microbiological tests.
  
  We want to do a trial, however before doing the full trial we need to develop a modified antibiotic guideline. The current guideline advises doctors which antibiotics to prescribe for a patient with HAP before any microbiology results are available. Our new guideline will need a section to incorporate the results of the FAPP; for example if X bacteria is detected give Y antibiotic.

  We will conduct an observational study of sputum samples provided by patients with (HAP) at two hospitals. Sputum samples will be analysed using the FAPP, in addition to routine microbiological testing. The routine microbiology results will be available as usual to the clinical teams but the FAPP results will be stored and interpreted retrospectively. Once 100 samples have been processed by the FAPP we will organise a meeting with experts to write a new section of the HAP treatment guideline based on an analysis of results from the FAPP.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  20/EE/0004

• Date of REC Opinion

  5 Mar 2020

• REC opinion

  Further Information Favourable Opinion