Shafiqa, N 
ORCID: 0009-0007-7506-9554, Aston, S ORCID: 0000-0002-0701-8364, Howard, A ORCID: 0000-0002-4195-6821, Turtle, L ORCID: 0000-0002-0778-1693, Abrams, S ORCID: 0000-0003-3949-2455, Young, B ORCID: 0000-0001-6041-9901, Sherratt, F ORCID: 0000-0003-4147-9305, Alvarez Nishio, A, Wilshaw, S, Jones, AP ORCID: 0000-0001-5253-730X et al (show 1 more authors)
(2024)
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® FILM ARRAY® pneumonia plus panel in adults with suspected non-ventilator-associated hospital-cquired pneumonia
BMJ Open, 14 (7).
e088490-.
ISSN 2044-6055, 2044-6055
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shafiqa n et al HAP-FAST protocol.pdf - Open Access published version Download (648kB) | Preview |
Abstract
Introduction Non-ventilator-associated hospital-acquired pneumonia (nv-HAP) is the most common healthcare-associated infection (HCAI), is associated with high mortality and morbidity and places a major burden on healthcare systems. Diagnosis currently relies on chest x-rays to confirm pneumonia and sputum cultures to determine the microbiological cause. This approach leads to over-diagnosis of pneumonia, rarely identifies a causative pathogen and perpetuates unnecessary and imprecise antibiotic use. The HAP-FAST study aims to evaluate the feasibility of a randomised trial to evaluate the clinical impact of low-dose, non-contrast-enhanced thoracic CT scans and rapid molecular sputum analysis using the BIOFIRE® FILMARRAY® pneumonia plus panel (FAPP) for patients suspected with nv-HAP. Methods and analysis The HAP-FAST feasibility study consists of a pilot randomised trial, a qualitative study, a costing analysis and exploratory analyses of clinical samples to investigate the immune-pathophysiology of HAP. Participants are identified and recruited from four acute hospitals in the Northwest of the UK. Using a Research Without Prior Consent model, the pilot trial will recruit 220 adult participants, with or without mental capacity, and with suspected HAP. HAP-FAST is a non-blinded, sequential, multiple assignment, randomised trial with two possible stages of randomisation: first, chest x-ray (CXR) or CT; second, if treated as nv-HAP, FAPP or standard microbiological processing alone (no FAPP). Pathogen-specific antibiotic guidance will be provided for FAPP results. Randomisation uses a web-based platform and followed up for 90 days. The feasibility of a future trial will be determined by assessing trial processes, outcome measures and patient and staff experiences. Ethics and dissemination This study has undergone combined review by the UK NHS Research Ethics Committee and Health Research Authority. Results will be disseminated via peer-reviewed journals, via the funders' website and through a range of media to engage the public. Trial registration number NCT05483309.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Sputum, Humans, Anti-Bacterial Agents, Tomography, X-Ray Computed, Radiography, Thoracic, Feasibility Studies, Pilot Projects, Qualitative Research, Adult, Male, Randomized Controlled Trials as Topic, Healthcare-Associated Pneumonia |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 23 Jul 2024 13:41 |
| Last Modified: | 24 Jan 2026 04:57 |
| DOI: | 10.1136/bmjopen-2024-088490 |
| Related Websites: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3183090 |
| Disclaimer: | The University of Liverpool is not responsible for content contained on other websites from links within repository metadata. Please contact us if you notice anything that appears incorrect or inappropriate. |
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