An observational study in Sepsis, Bloodstream Infection and Bacteraemia, sponsored by Liverpool University Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Liverpool University Hospitals NHS Foundation Trust · Observational
The goal of this study is to create a computer simulation of patients with bloodstream infection to understand how changes in healthcare policies and resources affect patient treatment. This simulation will help doctors and health-care decision makers make better choices in treating these patients and avoid overusing antibiotics that can lead to antibiotic resistance. Antibiotic resistance is when bacteria can't be killed by antibiotics anymore. Participants will not receive treatments as this is an observational study, but the study will involve:
The main aim of this research is to create a computer simulation of patients with bloodstream infection. Bloodstream infection is often a severe infection (blood poisoning) that can lead to sepsis, which is a significant global health concern, causing around 66,096 deaths each year in the United Kingdom alone. Doctors and healthcare decision-makers have to make difficult decisions that balance the effective treatment of patients with sepsis and avoid the overuse of broad-spectrum antibiotics, which can lead to antibiotic resistance. By generating a virtual environment to test out different scenarios, this computer simulation model will provide insight into the projected effects of changes to hospital policy, changes in hospital resources (such as staff) and the impact of laboratory diagnostic tests. Proposed changes can be simulated in this virtual environment prior to implementation in the real healthcare system.
This study will be carried out in three parts. First, there will be interviews with healthcare staff over six months to comprehensively describe the patient pathways involved in management of bloodstream infection. Next, the project will analyse historical pseudonymised data from Liverpool University Hospitals NHS Foundation and Liverpool Clinical Laboratories to inform the characteristics of the model (in particular on the bacteria causing infections, the antibiotic treatments used, and the time it takes for patients to be treated). Finally, there will be a 30-day observational study where researchers observe the treatment of patients with bloodstream infection (without intervening or recording identifying details) to ensure that the computer model captures all the important steps involved in patient management.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 100 is below the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Liverpool University Hospitals NHS Foundation Trust is the lead sponsor of 61 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with presumed bloodstream infection/sepsis/systemic infection.
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Sub-study 2 (retrospective data collection)
Exclusion Criteria:
Generation of a software simulation model that is fine tuned to the observed data.
The main outcome is the generation of a software simulation model that is calibrated to the observed data. The study team consists of individuals with experience in model construction and calibration.
Time frame: 2 years
Exploration of the performance of the model in different hypothesised scenarios.
Secondary outcomes of this study are the exploration of the performance of the model in different hypothesised scenarios. The scenarios and outcome metrics are dependant on the final model delivered, but as an example may include the following: Time from presentation to hospital to time to administration of antibiotics active against the infecting pathogen in a simulated model which includes a novel diagnostic test for antimicrobial resistance, vs a model that does not include one.
Time frame: 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Started Sep 2024 (actual). Primary completion is estimated for Dec 2025, 15 months after the start.
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Liverpool University Hospitals NHS Foundation Trust