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 <i>plus</i> panel in adults with suspected non-ventilator-associated hospital-cquired pneumonia.

Shafiqa, Natalia; Aston, Stephen; Howard, Alex; Turtle, Lance; Abrams, Simon; Young, Bridget; Sherratt, Frances; Alvarez Nishio, Anica; Wilshaw, Stephanie; Jones, Ashley P; Wootton, Dan G

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.

Shafiqa, Natalia; Aston, Stephen; Howard, Alex; Turtle, Lance; Abrams, Simon; Young, Bridget; Sherratt, Frances; Alvarez Nishio, Anica; Wilshaw, Stephanie; Jones, Ashley P; Wootton, Dan G.

Afiliación

Shafiqa N; Department of Clinical Infection, Microbiology and Immunology (CIMI), University of Liverpool, Liverpool, UK.
Aston S; Department of Respiratory Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.
Howard A; Tropical and Infectious Diseases Unit, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.
Turtle L; Department of Antimicrobial Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.
Abrams S; Department of Antimicrobial Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.
Young B; Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.
Sherratt F; Department of Clinical Infection, Microbiology and Immunology (CIMI), University of Liverpool, Liverpool, UK.
Alvarez Nishio A; Tropical and Infectious Diseases Unit, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.
Wilshaw S; NIHR Health Protection Research Unit for Emerging and Zoonotic Infections, University of Liverpool, Liverpool, UK.
Jones AP; Department of Clinical Infection, Microbiology and Immunology (CIMI), University of Liverpool, Liverpool, UK.
Wootton DG; Institute of Population Health, Department of Public Health, Policy and Systems, University of Liverpool, Liverpool, UK.

BMJ Open ; 14(7): e088490, 2024 Jul 04.

Article en En | MEDLINE | ID: mdl-38964799

ABSTRACT

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.

Asunto(s)

Antibacterianos; Estudios de Factibilidad; Neumonía Asociada a la Atención Médica; Tomografía Computarizada por Rayos X; Humanos; Antibacterianos/uso terapéutico; Tomografía Computarizada por Rayos X/métodos; Tomografía Computarizada por Rayos X/economía; Proyectos Piloto; Neumonía Asociada a la Atención Médica/diagnóstico por imagen; Neumonía Asociada a la Atención Médica/tratamiento farmacológico; Radiografía Torácica/economía; Radiografía Torácica/métodos; Adulto; Esputo/microbiología; Ensayos Clínicos Controlados Aleatorios como Asunto; Investigación Cualitativa; Masculino

Palabras clave

Diagnostic microbiology; Diagnostic radiology; RESPIRATORY MEDICINE (see Thoracic Medicine); Respiratory infections

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tomografía Computarizada por Rayos X / Estudios de Factibilidad / Neumonía Asociada a la Atención Médica / Antibacterianos Límite: Adult / Humans / Male Idioma: En Revista: BMJ Open Año: 2024 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Reino Unido

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