Feasibility Study of Contemporary Diagnostics for Patients With Suspected Hospital-Acquired Pneumonia.
HAP-FAST
Feasibility Study of the Clinical and Cost-effectiveness of Contemporary Diagnostics for Patients With Suspected Hospital-Acquired Pneumonia (HAP).
1 other identifier
interventional
220
1 country
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2022
CompletedFirst Posted
Study publicly available on registry
August 2, 2022
CompletedStudy Start
First participant enrolled
June 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2025
CompletedSeptember 5, 2025
January 1, 2024
2 years
July 5, 2022
August 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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
Day 90
Estimate population statistics for each DTR - Antibiotic usage
Day 90
Estimate population statistics for each DTR - Change to Quality of Life
Baseline, day 10, 28 and 90
Estimate population statistics for each DTR - Length of hospital stay
Day 90
Estimate population statistics for each DTR - Mortality
Day 14, 28 and 90
- +10 more secondary outcomes
Study Arms (4)
Diagnostic Treatment Regimen 1
EXPERIMENTALPatients will receive a chest x-ray and their sputum sample will be analysed using the FilmArray Pneumonia Panel.
Diagnostic Treatment Regimen 2
NO INTERVENTIONPatients will receive a chest x-ray and their sputum sample will not be analysed using the FilmArray Pneumonia Panel.
Diagnostic Treatment Regimen 3
EXPERIMENTALPatients will receive a CT scan and their sputum sample will be analysed using the FilmArray Pneumonia Panel.
Diagnostic Treatment Regimen 4
EXPERIMENTALPatients will receive a CT scan and their sputum sample will not be analysed using the FilmArray Pneumonia Panel.
Interventions
Patients receive a CT scan
The FilmArray Pneumonia Panel is used to analysis the patient's sputum sample for the cause of the hospital acquired pneumonia
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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\*\*
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Liverpool University Hospitals NHS Foundation Trust
Liverpool, L69 7BE, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Lancashire teaching hospitals NHS Foundation Trust
Preston, United Kingdom
Related Publications (1)
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.
PMID: 38964799DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2022
First Posted
August 2, 2022
Study Start
June 13, 2023
Primary Completion
June 11, 2025
Study Completion
June 11, 2025
Last Updated
September 5, 2025
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share