A study to determine which bacteria and viruses are detected in patients who develop pneumonia while in hospital
| ISRCTN | ISRCTN20805366 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20805366 |
| IRAS number | 268957 |
| Secondary identifying numbers | UoL001494, IRAS 268957, CPMS 44564 |
- Submission date
- 09/02/2022
- Registration date
- 04/05/2022
- Last edited
- 07/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Hospital-Acquired Pneumonia (HAP) is a common and serious lung infection that occurs in all hospitals and on all wards. It particularly affects elderly patients. A new test called is available to help doctors decide which treatment to use for a patient with HAP. The test is called 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.
HAPOSS is a preliminary study aimed at describing how oftern different casues of HAP the FAPP would be detected if it were it were to be used in an NHS hospital.
Who can participate?
Adult patients (18 years or older) whose doctor wants to treat them for HAP.
What does the study involve?
HAPOSS involves using the FAPP to test a patient's sputum sample.
What are the benefits and risks of participating?
There are no direct benefits to patients who participate in HAPOSS however the results obtained will benefit future patients with HAP.
There are no risks associated with participation in HAPOSS.
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.
Where is the study run from?
The study is run by a team who work at the University of Liverpool and the Liverpool University Hospitals NHS Foundation Trust (UK).
When is the study starting and how long is it expected to run for?
September 2018 to August 2022
Who is funding the study?
University of Liverpool (UK)
Who is the main contact?
Dr Dan Wootton, dwootton@liverpool.ac.uk
Contact information
Scientific
Ronald Ross Building
8 West Derby Street
Liverpool
L7 3EA
United Kingdom
 ORCID ID |
0000-0002-5903-3881 |
|---|---|
| Phone | +44 151 795 9647 |
| dwootton@liverpool.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 41128 HAPOSS PIL v2 13Feb2020.pdf |
| Scientific title | Hospital Acquired Pneumonia Study of Sputum |
| Study acronym | HAPOSS |
| Study objectives | The aim of HAPOSS is to describe the pattern of pathogen detections made by the bioFire Film Array Pneumonia Panel when used to sample a representative cohort of patients treated for non-ventilator acquired Hospital Acquired Pneumonia. |
| Ethics approval(s) | Approved 05/03/2020, East of England - Cambridge Central Research Ethics Committee (Royal Standard Place, Nottingham, NG1 6FS, UK; +44 2071048270; CambridgeCentral.rec@hra.nhs.uk), ref: 20/EE/0004 |
| Health condition(s) or problem(s) studied | Non ventilator acquired hospital acquired pneumonia |
| Intervention | The population of interest are patients who are about to be treated for non-ventilator acquired hospital acquired pneumonia (HAP). At the descretion of the treating clinical team, sputum samples, obtained as part of standard clinical practice, are sub-sampled and tested using the bioFire FilmArray Pneumonia Panel. The remaining sputum is sent for standard microbiological investigations which are reported in the usual way. Results of the bioFire FilmArray Pneumonia Panel test are not revealed to the clinical team but are stored and analysed retrospectively. Analysis will be descriptive and the results will be summary statistics such as frequency counts and proportions of individual pathogens detected, multiple pathogen detections and resistance genes detected. The interpretation will be perfomed in the light of local and national treatment guidelines. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | bioFire FilmArray Pneumonia Panel |
| Primary outcome measure | Pneumonia pathogens are detected at baseline using the bioFire® FilmArray® Pneumonia Panel Plus |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 11/09/2018 |
| Completion date | 01/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | Adults of 16 years or older who are treated as HAP within the two recruiting hospitals |
| Key exclusion criteria | 1. Intention is to palliate rather than cure 2. Non-English speaking 3. Patients from whom a sputum sample cannot be obtained within 6 hours of the administration |
| Date of first enrolment | 01/08/2021 |
| Date of final enrolment | 01/08/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Prescot Street
Liverpool
L7 8XP
United Kingdom
Sponsor information
University/education
Clinical Directorate
4th Floor Thompson Yates Building
Faculty of Health and Life Sciences
Liverpool
L69 3GB
England
United Kingdom
| Phone | +44 7717 863747 |
|---|---|
| sponsor@liverpool.ac.uk | |
| Website | https://www.liverpool.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The University of Liverpool, 利物浦大学, Universidad de Liverpool, UoL
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 13/02/2020 | 15/02/2022 | No | Yes |
| Protocol file | version 5 | 10/02/2020 | 15/02/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
07/06/2022: Internal review.
15/02/2022: Trial's existence confirmed by East of England - Cambridge Central Research Ethics Committee.
