{
  "abstract": "Introduction Sepsis is a life-threatening syndrome resulting from a dysregulated immune response to an infection. Patients with sepsis can become critically ill and require advanced organ support in a hospital critical care setting. Antibiotics are lifesaving in sepsis, but overuse is associated with harm and promotes antimicrobial resistance, a rising global challenge making antibiotic treatment less effective. The prevalence of antibiotic use is very high in patients admitted to critical care. Research indicates that shorter courses of antibiotics are as effective as longer durations in the treatment of certain infections, but uncertainty remains for patients with sepsis. The aim of SHORTER is to investigate whether treating critically ill patients with suspected or confirmed sepsis with a fixed 5-day, short course of antibiotics is clinically and cost-effective compared with standard of care.Methods and analysis SHORTER is a pragmatic, multicentre, randomised controlled trial. 2244 adults treated with antibiotics for suspected or confirmed sepsis in a critical care setting will be recruited from 50 UK National Health Service hospitals. Participants will be randomised to either a fixed 5-day index course of antibiotics (intervention) or standard of care duration antibiotics (control). The coprimary outcomes are 28-day mortality (non-inferiority) and antibiotic treatment days (superiority). Secondary outcomes will assess the effect of short-duration antibiotic therapy on 90-day mortality, hospital readmissions, further infection rates and health economic impacts. A process evaluation will be embedded in the trial.Ethics and dissemination Favourable ethical opinion has been received from the Wales Research Ethics Committee 4 (Ref: 23/WA/0197) and Scotland A REC (Ref: 24/SS/0013). Results will be publicly disseminated via Patient Public Involvement and Engagement representatives, charities and media, and to the clinical community via professional societies, peer-reviewed publications and conference presentations.Trial registration number ISRCTN40090372.",
  "authors": [
    {
      "affiliations": [
        "Newcastle University Translational and Clinical Research Institute, Newcastle upon Tyne, UK"
      ],
      "name": "Phil Mawson"
    },
    {
      "affiliations": [
        "Newcastle Clinical Trials Unit, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK"
      ],
      "name": "Miranda Morton"
    },
    {
      "affiliations": [
        "Newcastle Clinical Trials Unit, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK"
      ],
      "name": "Zoe Walmsley"
    },
    {
      "affiliations": [
        "Newcastle Clinical Trials Unit, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK"
      ],
      "name": "Rebecca Wafer"
    },
    {
      "affiliations": [
        "Newcastle Clinical Trials Unit, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK"
      ],
      "name": "Helen C Hancock"
    },
    {
      "affiliations": [
        "Biostatistics Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK"
      ],
      "name": "Helen Mossop"
    },
    {
      "affiliations": [
        "Biostatistics Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK"
      ],
      "name": "Sarah Al-Ashmori"
    },
    {
      "affiliations": [
        "The Medical School, University of Exeter, University of Exeter, Exeter, UK",
        "Queen’s University Belfast Wellcome-Wolfson Institute for Experimental Medicine, Belfast, UK"
      ],
      "name": "Lydia M Emerson"
    },
    {
      "affiliations": [
        "School of Health & Social Care, Edinburgh Napier University, Edinburgh, UK"
      ],
      "name": "Jamie Smith"
    },
    {
      "affiliations": [
        "School of Health & Social Care, Edinburgh Napier University, Edinburgh, UK",
        "Division of Research Methodology, Wrocław Medical University, Wrocław, Poland"
      ],
      "name": "Gosha Colquhoun"
    },
    {
      "affiliations": [
        "Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK"
      ],
      "name": "Hangjian Wu"
    },
    {
      "affiliations": [
        "Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK"
      ],
      "name": "Cristina Fernandez-Garcia"
    },
    {
      "affiliations": [
        "Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK"
      ],
      "name": "Laura Ternent"
    },
    {
      "affiliations": [
        "Patient and Public Involvement Partner, United Kingdom, UK"
      ],
      "name": "Rashmi Kumar"
    },
    {
      "affiliations": [
        "Patient and Public Involvement Partner, United Kingdom, UK"
      ],
      "name": "Margaret Ogden"
    },
    {
      "affiliations": [
        "Newcastle Joint Research Office, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK"
      ],
      "name": "Laura Loraine"
    },
    {
      "affiliations": [
        "Newcastle Clinical Trials Unit, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK"
      ],
      "name": "Leia Taylor"
    },
    {
      "affiliations": [
        "Newcastle Clinical Trials Unit, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK"
      ],
      "name": "Sipho Ndlovu"
    },
    {
      "affiliations": [
        "Newcastle University Translational and Clinical Research Institute, Newcastle upon Tyne, UK"
      ],
      "name": "Phil Hall"
    },
    {
      "affiliations": [
        "Division of Anaesthetics, Pain Medicine and Intensive Care, Imperial College London, London, UK"
      ],
      "name": "Anthony C Gordon"
    },
    {
      "affiliations": [
        "Newcastle University Translational and Clinical Research Institute, Newcastle upon Tyne, UK"
      ],
      "name": "Anthony Rostron"
    },
    {
      "affiliations": [
        "Department of Medical Microbiology, Queen’s University Belfast Wellcome-Wolfson Institute for Experimental Medicine, Belfast, UK"
      ],
      "name": "Ronan McMullan"
    },
    {
      "affiliations": [
        "Division of Immunology, Immunity to Infection and Respiratory Medicine, University of Manchester, Manchester, UK"
      ],
      "name": "Tim Felton"
    },
    {
      "affiliations": [
        "Usher Institute of Population Health Sciences, The University of Edinburgh, Edinburgh, UK"
      ],
      "name": "Timothy Walsh"
    },
    {
      "affiliations": [
        "Queen’s University Belfast Wellcome-Wolfson Institute for Experimental Medicine, Belfast, UK"
      ],
      "name": "Daniel Francis McAuley"
    },
    {
      "affiliations": [
        "Division of Immunology, Immunity to Infection and Respiratory Medicine, University of Manchester, Manchester, UK"
      ],
      "name": "Paul Dark"
    },
    {
      "affiliations": [
        "Newcastle University Translational and Clinical Research Institute, Newcastle upon Tyne, UK",
        "Respiratory Medicine Unit, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK"
      ],
      "name": "A John Simpson"
    },
    {
      "affiliations": [
        "Newcastle University Translational and Clinical Research Institute, Newcastle upon Tyne, UK",
        "Newcastle Clinical Trials Unit, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK",
        "Department Critical Care, Royal Victoria Infirmary, Newcastle Upon Tyne Hospitals NHS Trust, Newcastle upon Tyne, UK"
      ],
      "name": "Thomas P Hellyer"
    }
  ],
  "title": "SHORTER trial: protocol for a pragmatic, multicentre, randomised controlled trial of short-duration antibiotic therapy for critically ill patients with sepsis",
  "uid": "4f5a3996-c002-528c-ba9d-c722d2b4f933"
}