{
  "abstract": "Background HAP is treated with broad spectrum antibiotics but a third of patients have no radiological evidence of a lung infiltrate and most are treated empirically. Therefore, opportunities exist to enhance antibiotic stewardship by improving the radiological and microbiological diagnosis of HAP.Aims Investigate the feasibility of a fully powered diagnostic trial in suspected HAP comparing: a) low-dose thoracic CT scan to chest x-ray b) BIOFIRE® FILMARRAY® Pneumonia Panel (FAPP) to standard microbiologyEvaluate trial endpoints and look for signals of efficacyMethods Funding: UK National Institute of Health and Care Research (NIHR300669)NHS combined Research Ethics/Health Research Authority approval: 22/WA/0315Trial registration: www.ClinicalTrials.gov/study/NCT05483309 Using a deferred consent model, clinicians at 4 hospitals randomised patients 1:1 to the interventions via a trial website. The research team later sought consent for ongoing participation. Stage one randomisation was between a routine chest x-ray and a low-dose, non-contrast enhanced thoracic CT scan. Then, patients requiring ongoing antibiotics who could produce a sputum sample were randomised for a second time between usual care (empirical antibiotics and standard microbiology) versus antibiotics informed by BIOFIRE® FILM ARRAY® pneumonia plus panel analysis of their sputum. Antibiotic prescribing in the FAPP arm was supported by a guideline. Participants were visited for 10 days or until discharge, at 28 and 90 days. Outcomes evaluated were mortality, clinical cure, quality of life, length of stay and antibiotic use.Results Recruitment (n=220) was completed ahead of schedule with a mean of 6 randomisations/site/month. Characteristics were similar between groups with a median age of 77 y (range 20–99). Of those randomised at stage 1 (CT v CXR) 28% were randomised at stage 2 (FAPP v standard micro). 65% of patients gave consent for ongoing participation. Median time to CT was 2 hours. Group differences were seen in antibiotic prescribing, mortality and several other outcome measures.Conclusion A multicentre trial of novel diagnostic pathways for patients suspected of HAP is feasible and there is evidence to support a fully powered trial of these interventions.",
  "authors": [
    {
      "affiliations": [
        "Department of Clinical Infection Microbiology and Immunology, University of Liverpool, Liverpool, UK",
        "Department of Respiratory Medicine, Aintree University Hospital, Liverpool, UK; University Hospitals of Liverpool Group, Liverpool, UK"
      ],
      "name": "D Wootton"
    },
    {
      "affiliations": [
        "Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK"
      ],
      "name": "I Powell"
    },
    {
      "affiliations": [
        "Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK"
      ],
      "name": "S Willshaw"
    },
    {
      "affiliations": [
        "Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK"
      ],
      "name": "A Tao"
    },
    {
      "affiliations": [
        "Department of Respiratory Medicine, Aintree University Hospital, Liverpool, UK; University Hospitals of Liverpool Group, Liverpool, UK"
      ],
      "name": "N Shafiqa"
    },
    {
      "affiliations": [
        "NHS University Hospitals of Liverpool Group, Liverpool, UK"
      ],
      "name": "E Adegbenro"
    },
    {
      "affiliations": [
        "The Emergency Department, NHS University Hospitals of Liverpool Group, Liverpool, UK"
      ],
      "name": "K Cook"
    },
    {
      "affiliations": [
        "Institute of Life course and Medical Sciences, University of Liverpool, Liverpool, UK"
      ],
      "name": "A Cross"
    },
    {
      "affiliations": [
        "NHS University Hospitals of Liverpool Group, Liverpool, UK"
      ],
      "name": "D Mclaughlan"
    },
    {
      "affiliations": [
        "Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK"
      ],
      "name": "H Singh"
    },
    {
      "affiliations": [
        "Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK"
      ],
      "name": "K Kalapurakal"
    },
    {
      "affiliations": [
        "Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK"
      ],
      "name": "N Senior"
    },
    {
      "affiliations": [
        "Department of Clinical Infection Microbiology and Immunology, University of Liverpool, Liverpool, UK",
        "Tropical and Infectious Diseases Unit, Royal Liverpool Hospital, NHS University Hospitals of Liverpool Group, Liverpool, UK"
      ],
      "name": "L Turtle"
    },
    {
      "affiliations": [
        "Tropical and Infectious Diseases Unit, Royal Liverpool Hospital, NHS University Hospitals of Liverpool Group, Liverpool, UK",
        "Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK"
      ],
      "name": "S Aston"
    },
    {
      "affiliations": [
        "Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK",
        "Department of Microbiology, Royal Liverpool Hospital, NHS University Hospitals of Liverpool Group, Liverpool, UK"
      ],
      "name": "AL Howard"
    },
    {
      "affiliations": [
        "Department of Respiratory Medicine, Royal Liverpool Hospital, NHS University Hospitals of Liverpool Group, Liverpool, UK"
      ],
      "name": "L Pilling"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK"
      ],
      "name": "R Bazaz"
    },
    {
      "affiliations": [
        "Department of Respiratory Medicine, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK"
      ],
      "name": "S Trewick"
    },
    {
      "affiliations": [
        "Independent PPI advisor, UK"
      ],
      "name": "I Poku"
    },
    {
      "affiliations": [
        "Independent PPI advisor, UK"
      ],
      "name": "A Alvarez-Nishio"
    },
    {
      "affiliations": [
        "Independent PPI advisor, UK"
      ],
      "name": "E Lam"
    },
    {
      "affiliations": [
        "Department of Clinical Infection Microbiology and Immunology, University of Liverpool, Liverpool, UK"
      ],
      "name": "S Abrams"
    },
    {
      "affiliations": [
        "Department of Clinical Infection Microbiology and Immunology, University of Liverpool, Liverpool, UK"
      ],
      "name": "A Collins"
    },
    {
      "affiliations": [
        "Institute of Population Health, University of Liverpool, Liverpool, UK"
      ],
      "name": "F Sherratt"
    },
    {
      "affiliations": [
        "Institute of Population Health, University of Liverpool, Liverpool, UK"
      ],
      "name": "B Young"
    },
    {
      "affiliations": [
        "Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK"
      ],
      "name": "A Jones"
    }
  ],
  "title": "S5 HAP-FAST: a pilot sequential multiple assignment randomised trial (SMART) 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-acquired pneumonia",
  "uid": "9f4d9dae-1d99-51c5-b762-8bc260c25ed4"
}