Hospital-acquired PneumoniaHAP-FASTNCT05483309
Feasibility Study of Contemporary Diagnostics for Patients With Suspected Hospital-Acquired Pneumonia.
A study testing CT scan and FilmArray Pneumonia Panel in people with Hospital-acquired Pneumonia, run by University of Liverpool at 3 sites in United Kingdom.
Trial summary
Hospital-Acquired Pneumonia (HAP) is a severe lung infection that develops while a patient is in hospital. We aim to design a trial to see if modern diagnostic investigations can safely improve outcomes for patients suspected of HAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital-acquired Pneumonia
- What is being tested?
- CT scan and FilmArray Pneumonia Panel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 13 Jun 2023to 11 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 1:
- Age ≥ 18 years
- Suspected HAP*
- For the purposes of this study, HAP is defined as per the BTS and FDA definitions i.e. pneumonia which develops 48 hours after an admission to hospital for an alternative diagnosis; or a new presentation to hospital with pneumonia in a patient who has been discharged from an overnight stay in hospital within the last 10 days.
- Stage 2:
- The clinician intends to treat the patient for HAP or a hospital acquired respiratory tract infection (RTI).
- A sputum sample has been obtained before 2nd dose of antibiotic.
Who cannot join
- Stage 1:
- Already received a chest X-ray to confirm suspected HAP diagnosis
- Diagnosis or suspected diagnosis of ventilator acquired pneumonia
- Intention to palliate rather than cure
- Interventions cannot be completed before administration of second antibiotic dose*
- Cannot be randomised to low-dose, non-contrast CT scan on clinical grounds e.g. strong suspicion of PE**
Show all 13Show fewer
- Pregnancy***
- Previous study participation (patients with second of third episodes of HAP will not be re-recruited)
- In the circumstance where a patient is diagnosed with HAP whist receiving antibiotics for a non-respiratory infection e.g. cellulitis or UTI, if the HAP diagnosis leads to a change in the antibiotic prescription to cover the HAP then that patient will be eligible for recruitment. However, if the diagnosis of HAP does not result in a change in antibiotic then the patient is not eligible.
- A non-contrast, low-dose thoracic CT scan is an inappropriate test for a PE and if that is high in the differential diagnosis then tick yes here.
- A urine pregnancy test is required as part of routine care prior to a chest X-ray or CT scan. If the test reveals the patient is pregnant, they will not be eligible for the study as they will be unable to receive a CT scan as part of this study. Pregnancy tests are not required at future time points.
- Stage 2:
- Following the CXR or CT the clinician decides not to treat with antibiotics for either HAP or a hospital acquired RTI.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Liverpool University Hospitals NHS Foundation Trust
Liverpool, L69 7BE
Manchester University NHS Foundation Trust
Manchester
Lancashire teaching hospitals NHS Foundation Trust
Preston
About this study
Official title: Feasibility Study of the Clinical and Cost-effectiveness of Contemporary Diagnostics for Patients With Suspected Hospital-Acquired Pneumonia (HAP).
Hospital-Acquired Pneumonia (HAP) is a severe lung infection that develops while a patient is in hospital. We aim to design a trial to see if modern diagnostic investigations can safely improve outcomes for patients suspected of HAP.
Currently, doctors use chest x-rays to make the diagnosis, but these are difficult to interpret and a third of patients suspected of HAP receive antibiotics inappropriately. Patients are concerned about misdiagnosis and a solution might be to replace the chest x-ray with a CT scan since these show the lungs in more detail.
Read more
Once a diagnosis of HAP is made, doctors would like to identify the bacteria or viruses responsible. However, current tests are too slow to determine the initial treatment, so guidelines suggest we cover a range of possibilities with two extended spectrum antibiotics. Patients tell us they are concerned, because these antibiotics increase the risk of severe side effects and promote antibiotic resistance. The BIOFIRE® FILMARRAY® pneumonia panel (FAPP) is a new test that can identify the cause of HAP quickly. If we can determine the best way to use the FAPP, we can give antibiotics more effectively and slow the development of antimicrobial resistance.
We will conduct a feasibility study to inform the design of a fully powered trial to discover whether using CT scans or the FAPP, or both together, helps improve antibiotic use and patient recovery whilst being cost effective.
We will interview some participants and staff about how the trial is working so that we can improve the design. We will list the costs associated with HAP so we can design a cost effectiveness evaluation for the definitive trial. We will use patient samples to investigate immune and inflammation related processes to better understand why some people develop HAP and why some become particularly unwell.
- Conditions
- Hospital-acquired Pneumonia
- Being tested
- CT scan, FilmArray Pneumonia Panel
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDiagnostic test
Patients receive a CT scan
FilmArray Pneumonia PanelDiagnostic test
The FilmArray Pneumonia Panel is used to analysis the patient's sputum sample for the cause of the hospital acquired pneumonia
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Treatment Regimen 1 | Experimental | Patients will receive a chest x-ray and their sputum sample will be analysed using the FilmArray Pneumonia Panel. Receives: Diagnostic Test: FilmArray Pneumonia Panel |
| Diagnostic Treatment Regimen 2 | No intervention | Patients will receive a chest x-ray and their sputum sample will not be analysed using the FilmArray Pneumonia Panel. |
| Diagnostic Treatment Regimen 3 | Experimental | Patients will receive a CT scan and their sputum sample will be analysed using the FilmArray Pneumonia Panel. Receives: Diagnostic Test: CT scan; Diagnostic Test: FilmArray Pneumonia Panel |
| Diagnostic Treatment Regimen 4 | Experimental | Patients will receive a CT scan and their sputum sample will not be analysed using the FilmArray Pneumonia Panel. Receives: Diagnostic Test: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of a full-scale Randomised Controlled Trial (RCT) comparing different diagnostic dynamic treatment regimens (DTRs) in adult patients suspected of HAP.
Rate of recruitment; proportion screened that meet eligibility criteria; proportion eligible that consent and where they present; proportion consented and randomised that complete study pathway as per protocol; proportion consented and randomised that withdraw from trial intervention or follow up.
Measured: Screening and randomisation (1 year); follow up (3 months); end of study analysis (9 months).
Secondary outcomes (15)
Estimate population statistics for each DTR - Time to clinical cure
Time to clinical cure, defined as the number of days from baseline when there is a combination of resolution of signs and symptoms present at enrolment and improvement or lack of progression of radiological signs.
Measured: Day 90
Estimate population statistics for each DTR - Antibiotic usage
Antibiotic usage for the HAP episode
Measured: Day 90
Estimate population statistics for each DTR - Change to Quality of Life
Change of quality of life using the EQ-5D-5L measure
Measured: Baseline, day 10, 28 and 90
Estimate population statistics for each DTR - Length of hospital stay
Length of hospital stay post HAP diagnosis.
Measured: Day 90
Estimate population statistics for each DTR - Mortality
We will evaluate the best way to record this by analysing: in-hospital mortality, survival at three timepoints.
Measured: Day 14, 28 and 90
Estimate number of eligible patients and the pattern of their presentation.
Hospital/ward type, time of day/day of week.
Measured: At end of study (15 months)
Estimate rates of successful follow up.
Participants who attend 28 day visit and complete the post discharge indirect cost survey at 90 days.
Measured: At end of study (15 months)
Estimate rates of completion of questionnaires.
EQ5D5L, CAP-sym, economic evaluation.
Measured: At end of study (15 months)
Test the web-based randomisation process and incorporate clinical and researcher feedback.
Qualitative conclusions based on staff focus groups.
Measured: During qualitative analysis throughout the study (up to 15 months)
Perform a costing analysis of HAP to inform the cost-effectiveness analysis for any definitive trial.
Summary statistics for numbers and types of costs with comparison between DTRs.
Measured: At end of study (15 months)
Assess human factors involved in delivery of the study and how the different diagnostic tests influence clinical decision making by conducting qualitative interviews and focus groups with healthcare workers and researchers.
Qualitative conclusions based on staff focus groups.
Measured: During qualitative analysis throughout the study (up to 15 months)
Evaluate willingness of clinicians to recruit to the study.
Qualitative conclusions based on staff focus groups.
Measured: During qualitative analysis throughout the study (up to 15 months)
Evaluate willingness of potential participants or their consultees to be recruited.
Qualitative conclusions based on participant and carer interviews.
Measured: During qualitative analysis throughout the study (up to 15 months)
Evaluate adherence to antibiotic guidelines and study protocol.
Summary statistics relating to antibiotic use in the pilot study with a comparison between the DTRs.
Measured: At end of study (15 months)
Assess the study participant and carer experience of participating in the study.
Qualitative interviews.
Measured: During qualitative analysis throughout the study (up to 15 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start13 Jun 2023
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospital-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483309
- Sponsor's protocol ID
- UoL001676
- Acronym
- HAP-FAST
- Status last verified
- Jan 2024
- First submitted
- 5 Jul 2022
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Shafiqa N, Aston S, Howard A, Turtle L, Abrams S, Young B, Sherratt F, Alvarez Nishio A, Wilshaw S, Jones AP, Wootton DG. HAP-FAST: a feasibility study incorporating qualitative, mechanistic and costing sub-studies alongside a randomised pilot trial comparing chest x-ray to low-dose CT scan and empirical antibiotics to antibiotics guided by the BIOFIRE(R) FILM ARRAY(R) pneumonia plus panel in adults with suspected non-ventilator-associated hospital-cquired pneumonia. BMJ Open. 2024 Jul 4;14(7):e088490. doi: 10.1136/bmjopen-2024-088490.
PubMed 38964799
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Clinical and Cost-effectiveness of Contemporary Diagnostics for Patients With Suspected Hospital-Acquired Pneumonia (HAP).
- ClinicalTrials.gov ID
- NCT05483309
- Acronym / sponsor ID
- HAP-FAST / UoL001676
- Conditions
- Hospital-acquired Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hospital-Acquired Pneumonia (HAP) is a severe lung infection that develops while a patient is in hospital. We aim to design a trial to see if modern diagnostic investigations can safely improve outcomes for patients suspected of HAP.
Currently, doctors use chest x-rays to make the diagnosis, but these are difficult to interpret and a third of patients suspected of HAP receive antibiotics inappropriately. Patients are concerned about misdiagnosis and a solution might be to replace the chest x-ray with a CT scan since these show the lungs in more detail.
Once a diagnosis of HAP is made, doctors would like to identify the bacteria or viruses responsible. However, current tests are too slow to determine the initial treatment, so guidelines suggest we cover a range of possibilities with two extended spectrum antibiotics. Patients tell us they are concerned, because these antibiotics increase the risk of severe side effects and promote antibiotic resistance. The BIOFIRE® FILMARRAY® pneumonia panel (FAPP) is a new test that can identify the cause of HAP quickly. If we can determine the best way to use the FAPP, we can give antibiotics more effectively and slow the development of antimicrobial resistance.
We will conduct a feasibility study to inform the design of a fully powered trial to discover whether using CT scans or the FAPP, or both together, helps improve antibiotic use and patient recovery whilst being cost effective.
We will interview some participants and staff about how the trial is working so that we can improve the design. We will list the costs associated with HAP so we can design a cost effectiveness evaluation for the definitive trial. We will use patient samples to investigate immune and inflammation related processes to better understand why some people develop HAP and why some become particularly unwell.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Treatment Regimen 1 | Experimental | Diagnostic Test: FilmArray Pneumonia PanelPatients will receive a chest x-ray and their sputum sample will be analysed using the FilmArray Pneumonia Panel. |
| Diagnostic Treatment Regimen 2 | No intervention | –Patients will receive a chest x-ray and their sputum sample will not be analysed using the FilmArray Pneumonia Panel. |
| Diagnostic Treatment Regimen 3 | Experimental | Diagnostic Test: CT scan, Diagnostic Test: FilmArray Pneumonia PanelPatients will receive a CT scan and their sputum sample will be analysed using the FilmArray Pneumonia Panel. |
| Diagnostic Treatment Regimen 4 | Experimental | Diagnostic Test: CT scanPatients will receive a CT scan and their sputum sample will not be analysed using the FilmArray Pneumonia Panel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Suspected HAP*
- For the purposes of this study, HAP is defined as per the BTS and FDA definitions i.e. pneumonia which develops 48 hours after an admission to hospital for an alternative diagnosis; or a new presentation to hospital with pneumonia in a patient who has been discharged from an overnight stay in hospital within the last 10 days.
- The clinician intends to treat the patient for HAP or a hospital acquired respiratory tract infection (RTI).
- A sputum sample has been obtained before 2nd dose of antibiotic.
Key exclusion criteria (13 listed)
- Already received a chest X-ray to confirm suspected HAP diagnosis
- Diagnosis or suspected diagnosis of ventilator acquired pneumonia
- Intention to palliate rather than cure
- Interventions cannot be completed before administration of second antibiotic dose*
- Cannot be randomised to low-dose, non-contrast CT scan on clinical grounds e.g. strong suspicion of PE**
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanPatients receive a CT scan | Diagnostic test | Diagnostic Treatment Regimen 3, Diagnostic Treatment Regimen 4 |
| FilmArray Pneumonia PanelThe FilmArray Pneumonia Panel is used to analysis the patient's sputum sample for the cause of the hospital acquired pneumonia | Diagnostic test | Diagnostic Treatment Regimen 1, Diagnostic Treatment Regimen 3 |
Primary outcome
Determine the feasibility of a full-scale Randomised Controlled Trial (RCT) comparing different diagnostic dynamic treatment regimens (DTRs) in adult patients suspected of HAP.
Time frame: Screening and randomisation (1 year); follow up (3 months); end of study analysis (9 months).
Rate of recruitment; proportion screened that meet eligibility criteria; proportion eligible that consent and where they present; proportion consented and randomised that complete study pathway as per protocol; proportion consented and randomised that withdraw from trial intervention or follow up.
15 secondary outcomes
Estimate population statistics for each DTR - Time to clinical cure
Time frame: Day 90
Estimate population statistics for each DTR - Antibiotic usage
Time frame: Day 90
Estimate population statistics for each DTR - Change to Quality of Life
Time frame: Baseline, day 10, 28 and 90
Estimate population statistics for each DTR - Length of hospital stay
Time frame: Day 90
Estimate population statistics for each DTR - Mortality
Time frame: Day 14, 28 and 90
Estimate number of eligible patients and the pattern of their presentation.
Time frame: At end of study (15 months)
Estimate rates of successful follow up.
Time frame: At end of study (15 months)
Estimate rates of completion of questionnaires.
Time frame: At end of study (15 months)
Test the web-based randomisation process and incorporate clinical and researcher feedback.
Time frame: During qualitative analysis throughout the study (up to 15 months)
Perform a costing analysis of HAP to inform the cost-effectiveness analysis for any definitive trial.
Time frame: At end of study (15 months)
Assess human factors involved in delivery of the study and how the different diagnostic tests influence clinical decision making by conducting qualitative interviews and focus groups with healthcare workers and researchers.
Time frame: During qualitative analysis throughout the study (up to 15 months)
Evaluate willingness of clinicians to recruit to the study.
Time frame: During qualitative analysis throughout the study (up to 15 months)
Evaluate willingness of potential participants or their consultees to be recruited.
Time frame: During qualitative analysis throughout the study (up to 15 months)
Evaluate adherence to antibiotic guidelines and study protocol.
Time frame: At end of study (15 months)
Assess the study participant and carer experience of participating in the study.
Time frame: During qualitative analysis throughout the study (up to 15 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Derived from this study: PubMed 38964799Shafiqa N, Aston S, Howard A, Turtle L, Abrams S, Young B, Sherratt F, Alvarez Nishio A, Wilshaw S, Jones AP, Wootton DG. HAP-FAST: a feasibility study incorporating qualitative, mechanistic and costing sub-studies alongside a randomised pilot trial comparing chest x-ray to low-dose CT scan and empirical antibiotics to antibiotics guided by the BIOFIRE(R) FILM ARRAY(R) pneumonia plus panel in adults with suspected non-ventilator-associated hospital-cquired pneumonia. BMJ Open. 2024 Jul 4;14(7):e088490. doi: 10.1136/bmjopen-2024-088490.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan and FilmArray Pneumonia Panel in people with Hospital-acquired Pneumonia, run by University of Liverpool at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the feasibility of a full-scale Randomised Controlled Trial (RCT) comparing different diagnostic dynamic treatment regimens (DTRs) in adult patients suspected of HAP. (time frame: Screening and randomisation (1 year); follow up (3 months); end of study analysis (9 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05483309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.