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Contact Information:

Dr Vicky Enne
inhale.study@uea.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Inhale work package 3 – rapid versus standard testing to diagnose lung infections in intensive care, including COVID-19 observational sub-study
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Inhale work package 3 – rapid versus standard testing to diagnose lung infections in intensive care, including COVID-19 observational sub-study

Not Recruiting

Open to: All Genders

Age: Adult

London London Liverpool Dudley Watford Great Yarmouth London Liverpool London Stoke on Trent London Birmingham London

Medical Conditions

Pneumonia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Severely ill hospital patients often develop lung and respiratory infections such as pneumonia. Such infections are life-threatening and must be treated as soon as possible with antibiotics. It is well known that not all antibiotics are working as well as they used to, this is largely due to resistance of the bacteria that cause the infections and has been listed as a major public health concern by the UK Department of Health and many other countries around the world. Current practice in hospitals, when a patient is suspected of having a lung infection, is to send a sample of their sputum (spit and phlegm mixture collected from their airways) to the microbiology lab for analysis. This takes 2-3 days, during that time the suspected infection is treated with a broad range of antibiotics. It has been found that this approach means around 67% of people with pneumonia receive antibiotics that they do not need, thus creating resistance risk and can cause unnecessary and unpleasant side effects to the patients themselves. The INHALE trial tests a rapid diagnostic machine (the Biofire "FilmArray") to see if sample results can be provided quicker than lab sample testing and if this leads to the best and most appropriate antibiotics being prescribed sooner.

Added 11/06/2020: During the COVID-19 pandemic, the main INHALE trial recruitment has had to be suspended. Staff at several participating ICUs have suggested results from the Pneumonia Panel could prove extremely useful in the management of COVID-19 patients who would otherwise be treated with non-specific antibiotics to treat possible secondary bacterial pneumonias. They have requested access to machines and reagents, which are approved ("CE marked") for clinical use. To accommodate this, and to maximise clinical potential, the researchers have designed an observational sub-study for current INHALE sites, to allow evaluation of the clinical use of the tests. This is distinct from the INHALE trial, providing useful data for patient and antibiotic management during the COVID-19 epidemic, allowing sites to remain open and engaged, ready to re-commence randomisation to the trial when necessary. Accordingly, the aim of the sub-study is to describe clinically, how useful the rapid Pneumonia Panel test is for the management of ICU patients during the COVID-19 outbreak.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jul 2019 31 Oct 2021

Publications

2025 Results article in https://pubmed.ncbi.nlm.nih.gov/40781331/ Secondary outcome on patient resource use and costs (added 12/08/2025)2026 Results article in https://pubmed.ncbi.nlm.nih.gov/39961847/ Co-primary outcomes (added 21/09/2026)2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34620213/ (added 06/09/2023)2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34099497/ (added 06/09/2023)2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37970680/ ICU prescribers’ views on the application of molecular diagnostics in HAP/VAP patients (added 17/09/2024)2025 Other publications in https://pubmed.ncbi.nlm.nih.gov/39907301/ The influence of clinicians' beliefs on the application of rapid molecular diagnostics in intensive care (added 07/02/2025)2026 Other publications in https://pubmed.ncbi.nlm.nih.gov/41877199/ Examining clinicians’ perceptions of, and their antibiotic prescribing behaviour when using rapid molecular diagnostic tests in intensive care (added 21/09/2026)

As part of usual care participants will provide samples of sputum for analysis. Participants will either have their samples tested in the usual way or in the usual way and with a new test which is being trialled in this study. Machine results should be available and reviewed within 8 hours of collection. All participants will have their sample sent to the lab regardless of whether it is also tested on the new machine, so all standard care options are also available to their doctor. Treatment will proceed as usual for all participants. To guide doctors in prescribing the most appropriate antibiotic according to resistance 'stewardship' guidelines, trial-specific guidance will also be provided.

Added 11/06/2020: Doctors will have the option to use the BioFire machine for patients in ICU who test positive for Covid-19. A small amount of anonymous data (they cannot be identified) is collected from their medical records to help understand how best to treat patients who have COVID-19 and secondary pneumonias.


In-patients in a participating ICU/CCU with suspected Lower Respiratory Tract Infections (LRTIs) including Hospital Acquired Pneumonia (HAP) or Ventilator Acquired Pneumonia (VAP) will be potentially eligible to participate.

You can take part if:



You may not be able to take part if:


1. Previous inclusion in work programme 32. Concurrent participation in the active phase (defined as within 30 days of primary end point) of an interventional trial not agreed as acceptable for co-enrolment by the local PIs of both trials. Participants will be permitted to co-enrol in studies that do not involve an intervention (e.g. observational studies).3. Moribund and/or not expected to live more than 48 h4. Presence of an existing directive to withhold life-sustaining treatment5. Prisoners or young offenders currently in custody of HM Prison Service or supervised by the probation service


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Free Hospital
    Pond Street
    London
    NW3 2QG
  • Great Ormond Street Hospital
    Great Ormond Street
    London
    WC1N 3JH
  • Royal Liverpool University Hospital
    Prescot Street
    Liverpool
    L7 8XP
  • Russells Hall Hospital
    Pensnett Road
    Dudley
    DY1 2HQ
  • Watford General Hospital
    Vicarage Road
    Watford
    WD18 0HB
  • James Paget University Hospitals NHS Foundation Trust
    Lowestoft Road Gorleston
    Great Yarmouth
    NR31 6LA
  • University College London Hospitals NHS Foundation Trust
    235 Euston Road
    London
    NW1 2BU
  • Aintree Hospital
    Lower Lane
    Liverpool
    L9 7AL
  • Chelsea and Westminster Hospital NHS Foundation Trust
    Chelsea and Westminster Hospital 369 Fulham Road
    London
    SW10 9NH
  • Staffordshire and Stoke on Trent Partnership NHS Trust
    Haywood Hospital High Lane Burslem
    Stoke on Trent
    ST6 7AG
  • BUPA Cromwell Hospital
    164-178 Cromwell Road
    London
    SW5 0TU
  • Birmingham Children's Hospital
    Steelhouse Lane
    Birmingham
    B4 6NH
  • Royal Brompton Hospital
    Sydney Street
    London
    SW3 6NP

There are no direct benefits to patients in hospital today but they will be playing an important part in helping the NHS to treat adults and children with pneumonia in the next few years. The risk is considered to be no higher than the normal care that they would receive if they do not take part in this study. No new drug is being tested and their doctor can prescribe all of the same medicines regardless of how their sample has been tested. The antibiotics given to help fight the participant’s lung infection can be changed if the results show this might help them get better quicker or that they don’t need the antibiotics. While the machine can identify the most common causes of pneumonia, there are some rare bacteria it cannot find. Therefore there is a small risk that participants might have one of these rare bacteria, in which case treatment may have to be changed again after 2-3 days, once the bacteria from their phlegm have been grown in the lab.

Dr Vicky Enne
inhale.study@uea.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University College London and funded by NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0514-20018.



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Read full details for Trial ID: ISRCTN16483855

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Last updated 21 September 2026

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