SepsisCSM-BSINCT06271031
Process Mapping and Data Collection to Inform a Computer Simulation Model of Hospitalised Patients With Bloodstream Infection, Sepsis and Systemic Infection
An observational study of Sepsis and Bloodstream Infection, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Bloodstream Infection, Bacteraemia
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with presumed bloodstream infection/sepsis/systemic infection.
Who may be able to join
- Sub-study 2 (retrospective data collection)
- Patients who were managed within a LUFT acute hospital site (Aintree or Royal) and had a concurrent blood culture investigation requested
- Age ≥ 18 years at the time of the study. Sub-study 3 (observational study)
- Patients with blood culture investigation requested during the observation period, and staff caring for the patients.
Who cannot join
- Age < 18 years at the time of the study
- Blood culture requested but patient not managed on an acute hospital site.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool University Hospitals Foundation Trust
Liverpool, L6 1AS
Heather Rogers, heather.rogers@liverpoolft.nhs.uk
About this study
Official title: Computer Simulation Model of Patients With Bloodstream Infection, Sepsis and Systemic Infection (CSM-BSI)
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:
- Interviews with healthcare staff to understand patient care pathways.
- Analysis of historical data on bacteria causing infections and antibiotic treatments.
- A 30-day observational study to observe patient treatment for bloodstream infections.
Read the detailed description
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.
- Conditions
- Sepsis, Bloodstream Infection, Bacteraemia
- Medical subject headings
- Sepsis, Toxemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Sep 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alessandro D Gerada, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271031
- Sponsor's protocol ID
- LHS0211
- Acronym
- CSM-BSI
- Status last verified
- Oct 2023
- First submitted
- 14 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Simulation Model of Patients With Bloodstream Infection, Sepsis and Systemic Infection (CSM-BSI)
- ClinicalTrials.gov ID
- NCT06271031
- Acronym / sponsor ID
- CSM-BSI / LHS0211
- Conditions
- Sepsis, Bloodstream Infection, Bacteraemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Interviews with healthcare staff to understand patient care pathways.
- Analysis of historical data on bacteria causing infections and antibiotic treatments.
- A 30-day observational study to observe patient treatment for bloodstream infections.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with presumed bloodstream infection/sepsis/systemic infection.
Key inclusion criteria (4 listed)
- Sub-study 2 (retrospective data collection)
- Patients who were managed within a LUFT acute hospital site (Aintree or Royal) and had a concurrent blood culture investigation requested
- Age ≥ 18 years at the time of the study. Sub-study 3 (observational study)
- Patients with blood culture investigation requested during the observation period, and staff caring for the patients.
Key exclusion criteria (2 listed)
- Age < 18 years at the time of the study
- Blood culture requested but patient not managed on an acute hospital site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Generation of a software simulation model that is fine tuned to the observed data.
Time frame: 2 years
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.
1 secondary outcome
Exploration of the performance of the model in different hypothesised scenarios.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro D Gerada principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Bloodstream Infection, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esha D Sheth (07864026738, e.d.m.sheth@liverpool.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generation of a software simulation model that is fine tuned to the observed data. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.