Toggle Main Menu Toggle Search

Open Access padlockePrints

SHORTER trial: protocol for a pragmatic, multicentre, randomised controlled trial of short-duration antibiotic therapy for critically ill patients with sepsis

Lookup NU author(s): Phil Mawson, Dr Miranda MortonORCiD, Zoe WalmsleyORCiD, Professor Helen HancockORCiD, Helen MossopORCiD, Sarah Al-Ashmori, Dr Hangjian WuORCiD, Dr Cristina Fernandez-GarciaORCiD, Professor Laura TernentORCiD, Leia Taylor, Sipho Ndlovu, Dr Philip Hall, Dr Anthony RostronORCiD, Professor John SimpsonORCiD, Dr Tom HellyerORCiD

Downloads


Licence

This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY. Published by BMJ Group.. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.IntroductionSepsis 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 analysisSHORTER 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 disseminationFavourable 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 numberISRCTN40090372.


Publication metadata

Author(s): Mawson P, Morton M, Walmsley Z, Wafer R, Hancock HC, Mossop H, Al-Ashmori S, Emerson LM, Smith J, Colquhoun G, Wu H, Fernandez-Garcia C, Ternent L, Kumar R, Ogden M, Loraine L, Taylor L, Ndlovu S, Hall P, Gordon AC, Rostron A, McMullan R, Felton T, Walsh T, McAuley DF, Dark P, Simpson AJ, Hellyer TP

Publication type: Article

Publication status: Published

Journal: BMJ Open

Year: 2026

Volume: 16

Issue: 3

Online publication date: 26/03/2026

Acceptance date: 25/02/2026

Date deposited: 15/04/2026

ISSN (print): elec-tronic

Publisher: BMJ Publishing Group

URL: https://doi.org/10.1136/bmjopen-2026-117142

DOI: 10.1136/bmjopen-2026-117142

PubMed id: 41887637


Altmetrics

Altmetrics provided by Altmetric


Funding

Funder referenceFunder name
NIHR Health Technology Assessment (HTA) Programme (NIHR134101)

Share