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Development of SMART PATH Sepsis Trial Protocol
Safe People
Organisation name
Imperial College London
Organisation sector
Academic Institute
Applicant name(s)
Timothy Rawson
Funders/ Sponsors
Graham Cooke
DEA accredited researcher?
Unknown
Sub-licence arrangements (if any)?
No
Safe Projects
Project ID
NIBDAPC_2025_0046
Lay summary
Sepsis is a life-threatening condition where the body’s response to an infection effects the function of its own tissues and organs. Sepsis requires urgent treatment with antibiotics and supportive care in the hospital. Failing to give the right antibiotic the first time in sepsis puts them at increased risk of death, side effects, and increases the risk of antibiotics not being as effective at treating infections in the future. There is little evidence on what the best antibiotic to give patients is. Patients and the public have told us that improving the way that we use antibiotics in sepsis is an important priority for research in Infectious Diseases. This project will help us to develop a new type of clinical trial which looks at antibiotic prescribing from start to finish. It will eventually give us information on the best sequence of antibiotics to prescribe for individual patients. To be able to design this type of trial, we first need more information. First, we need to know whether a patient is at high or low risk of a drug-resistant infection when they are diagnosed with sepsis. This will allow us to make sure that we make safe choices of initial antibiotics to start our patients on. Second, we need to model how such a clinical trial would run and estimate what the outcome might be. To do this, we first need to look at what is already being done in practice and use this information to create models of the trial. To explore how to predict a patient’s risk of drug-resistant infection and model how a clinical trial would work, we can use data within the iCARE trusted research environment to quickly and accurately achieve these aims.
Public benefit statement
This project is part of a larger piece of research that aims to put individual patients at the centre of antibiotic prescribing research and develop clinical trial infrastructure that delivers improved patient outcomes in real-world scenarios, such as patients diagnosed with sepsis. The outcomes of this proposed project are: 1. To develop and validate a risk prediction tool that can identify patients at high risk of infection with a drug-resistant infection. The developed tool will subsequently be used as part of a clinical trial to guide antibiotic selection for patients with a diagnosis of sepsis. This will hopefully improve appropriateness of antibiotic prescribing. 2. To design and test the feasibility of a clinical trial for antibiotic prescribing in hospitalised patients before it is run in real-life. This will allow us to ensure that interventions implemented in the trial are safe and effective for patients with infection. Successful delivery of the trial designed within this project will change our approach to the treatment of infections and allow us to consider how best to address challenges such as antimicrobial resistance in real-world practice.
Request category type
Public Health Research
Other approval committees
Project start date
30/06/2025
Latest approval date
11/06/2025
Safe Data
Dataset(s) name
ICHT iCARE Data Model
Data sensitivity level
De-Personalised
Common Law Duty of Confidentiality
Not applicable
National data opt-out applied?
Not applicable
Request frequency
One-off
Release/Access date
30/06/2025
Safe Setting
Access type
TRE