High, Juliet http://orcid.org/0000-0003-2555-2349
Enne, Virve I.
Barber, Julie A.
Brealey, David
Turner, David A.
Horne, Robert
Peters, Mark
Dhesi, Zaneeta
Wagner, Adam P.
Pandolfo, Alyssa M.
Stirling, Sue
Russell, Charlotte
O’Grady, Justin
Swart, Ann Marie
Gant, Vanya
Livermore, David M.
,
Funding for this research was provided by:
Programme Grants for Applied Research (RP-PG-0514-20018)
Article History
Received: 23 October 2020
Accepted: 13 September 2021
First Online: 7 October 2021
Declarations
:
: The protocol has been approved by the London - Brighton and Sussex Research Ethics Committee (19/LO/0400), the Health Research Authority (HRA), and has received local Trust approvals. It was developed with reference to the SPIRIT [CitationRef removed] and TIDieR guidelines [CitationRef removed].An Independent Data Monitoring Committee (DMC) has been convened to monitor the safety and progress of the trial, including adverse events and antibiotic-related side effects as well as significant patterns in the effectiveness of each treatment arm. In conjunction with the Trials Steering Committee (TSC), they can recommend premature closure of the trial following clear evidence of benefit or harm in accordance with their respective Terms of Reference.A key ethical consideration of this trial is that patients in ICUs often lack the capacity to consent for themselves and the trial is to be conducted in an emergency setting, where consent cannot reasonably be taken before intervention. The aims of the trial are incompatible with only entering patients with capacity and who are able to consent quickly, as it is important to ensure that the findings can be generalised to clinical practice. The trial is not looking at an invasive treatment or medicine; the same antibiotics and decisions are available to clinicians at all times, and they may choose to disregard the FilmArray results and algorithm guidance if clinically indicated. Therefore, consent to participate will be obtained as soon as reasonably appropriate and as described within the manuscript.
: Not applicable
: DML: Advisory Boards or ad hoc consultancy Accelerate, Allecra, Antabio, Centauri, Entasis, GSK, Integra-Holdings, Meiji, Melinta, Menarini, Mutabilis, Nordic, ParaPharm, Pfizer, QPEX, Roche, Russian Direct Investment Fund, Shionogi, Sumitovant, Summit, T.A.Z., Tetraphase, VenatoRx, Wockhardt, Zambon, Paid lectures – Accelerate, bioMerieux, Beckman Coulter, Cardiome, Cepheid, GSK, Hikma, Merck/MSD, Menarini, Nordic and Pfizer and Shionogi. Relevant shareholdings or options in Dechra, GSK, Merck, Perkin Elmer, Pfizer and T.A.Z, amounting to < 10% of portfolio value. He also has nominated holdings in Avacta, Diaceutics, Evgen, Faron, Genedrive, Renalytics and Synairgen (all with research/products pertinent to medical and diagnostic innovation) through Enterprise Investment Schemes, but has no authority to trade these shares directly.VE has received speaking honoraria, consultancy fees and in-kind contributions from several diagnostic companies including Curetis GmbH, bioMérieux and Oxford Nanopore.DB has received speaking honoraria or consultancy fees from bioMérieux, Gilead and T2 Biosystems.JOG has received speaking honoraria, consultancy fees, in-kind contributions or research funding from Oxford Nanopore, Simcere, Becton-Dickinson and Heraeus Medical.VG has received speaking honoraria from BioMérieux and support for Conference attendances from Merck/MSD and Gilead.The other authors declare no competing interests.