Process Mapping and Data Collection to Inform a Computer Simulation Model of Hospitalised Patients With Bloodstream Infection, Sepsis and Systemic Infection

NCT06271031 | Recruiting

• 1 other identifier: LHS0211
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sepsis; Bloodstream Infection; Bacteraemia

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Exploration of the performance of the model in different hypothesised scenarios.

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with presumed bloodstream infection/sepsis/systemic infection.

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18 years at the time of the study
• Blood culture requested but patient not managed on an acute hospital site.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Liverpool University Hospitals Foundation Trust

Liverpool, L6 1AS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sepsis; Toxemia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alessandro D Gerada

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esha D Sheth

CONTACT

07864026738; e.d.m.sheth@liverpool.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2023-10

Locations

GB (1)