Tracking anti-microbial resistance across care settings in Liverpool (TRACS- Liverpool) - Part 1

ISRCTN ISRCTN11601053
DOI https://doi.org/10.1186/ISRCTN11601053
IRAS number 309060
Secondary identifying numbers Sponsor 21-089, IRAS 309060, CPMS 51757
Submission date
09/12/2021
Registration date
17/12/2021
Last edited
30/03/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
This mixed methods study is the first stage of a programme of research looking at how antimicrobial resistance is acquired and transmitted within care settings in Liverpool.
Antimicrobial resistance (AMR) threatens the effectiveness of antibiotics that are widely used in modern medicine. Some resistant bacteria pose a particular threat, namely a group called Enterobacterales. These bacteria become resistant to antimicrobials when they acquire genes that enable the bacteria to produce enzymes that destroy antibiotics. People frequently carry these resistant bacteria without knowing. But in some cases they cause illness that can be life threatening or untreatable.
Although we understand how people can acquire these bacteria – either through direct exposure, such as swallowing them, or through exposure to antibiotics; it is less clear when and how these resistant bacteria are transmitted.
We know that people requiring frequent hospital admissions, or who live in long term care facilities are at particular risk of acquiring resistant bacteria.
We also know that rates of antimicrobial resistance are higher in the north-west than in the rest of the UK.
In order to be able to accurately plan and explore the problem of antimicrobial resistance locally we first need to understand it.

Who can participate?
Health professionals working in institutions that operate in Merseyside with knowledge and experience relevant to the research questions.

What does the study involve?
We will interview up to 50 key informants from local health and care organisations in order to gain a deeper understanding of how the hospital and care systems work locally. These participants will be identified by their key roles within health and care settings across Liverpool and will be invited to take part accordingly.
We will compare this information with specific datasets about antimicrobial resistant infection rates from selected local hospitals.
Combining these different sources of information will allow us to identify how and where potential transmission may be occurring. We can then accurately plan how to explore this further in the next stage of the research.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Liverpool School of Tropical Medicine (UK)

When is the study starting and how long is it expected to run for?
October 2021 to September 2022

Who is funding the study?
UKRI Strength in Places Fund (UK)
Unilever (UK)

Who is the main contact?
Maria Moore, maria.moore@lstmed.ac.uk

Contact information

Ms Maria Moore
Public

Liverpool Life Sciences Accelerator - Room 321
Liverpool School of Tropical Medicine
Liverpool
L7 8XZ
United Kingdom

ORCiD logoORCID ID 0000-0001-6456-927X
Phone +44 151 705 2566
Email maria.moore@lstmed.ac.uk
Dr Joseph M Lewis
Scientific

Department of Clinical Infection, Microbiology and Immunity
University of Liverpool
8 West Derby Street
Liverpool
L69 7BE
United Kingdom

ORCiD logoORCID ID 0000-0002-3837-5188
Phone +44 151 795 9687
Email jmlewis@liverpool.ac.uk

Study information

Study designObservational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleTracking anti-microbial resistance across care settings in Liverpool (TRACS-Liverpool) Part 1: informing the design and development of an observational cohort study
Study acronymTRACS - Liverpool: Part 1
Study hypothesisRationale for the study:
1. To inform the development of survey questions for a future longitudinal cohort study.
2. To inform the development of the sampling and recruitment strategies for the longitudinal cohort study.
3. To estimate rates of ESBL-E/CPE acquisition and infection in two Liverpool acute hospitals to inform sample size calculations.
4. To scope and document relevant routine and secondary data sources on local ESBL-E/CPE transmission
5. To document key informants’ perspectives on the acceptability of the Part 2 study and how to improve it.
6. To map facility infrastructure, describe patient journeys within and between care facilities, and suggest how these might affect ESBL-E/CPE acquisition and prevention.
7. To review and summarise infection control policies for ESBL and CPE and suggest how these might be linked to protection from or acquisition of ESBL/CPE
Ethics approval(s)Approved 16/02/2022, North West - Greater Manchester South Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ; +44(0)207 104 8143; gmsouthrec@hra.nhs.uk), ref:22/NW/0032
ConditionInfection control
InterventionFollowing enrolment participants will undertake a single semi-structured interview with the research team. This may be online or face-to-face. This will complete their involvement in the study.
Intervention typeOther
Primary outcome measure1.1. Estimate rates of ESBL-E/CPE acquisition and infection in two Liverpool acute hospitals, using readily available routine data sources at a single time point
Measured using interviews at a single time point:
2.1. Scope and document relevant routine and secondary data sources on local ESBL-E/CPE transmission.
2.2. Document key informants’ perspectives on the acceptability of the Part 2 study and how to improve it.
2.3. Map facility infrastructure, describe patient journeys within and between care facilities, and suggest how these might affect ESBL-E/CPE acquisition and prevention.
2.4. Review and summarise infection control policies for ESBL and CPE and suggest how these might be linked to protection from or acquisition of ESBL/CPE
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/10/2021
Overall study end date30/09/2022

Eligibility

Participant type(s)Health professional
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants45
Participant inclusion criteria1. Male or female aged 18 years or above
2. Health professionals working in institutions that operate in Merseyside
3. Having knowledge and/or experience to share on the research questions
4. Able to facilitate access to relevant data required in the study
5. Willing and able to give informed consent for participation in the study
Participant exclusion criteria1. Not willing or available to participate in the study
Recruitment start date01/02/2022
Recruitment end date30/04/2022

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Royal Liverpool Hospital
Liverpool University Hospitals Foundation NHS Trust
Prescot Street
Liverpool
L7 8XP
United Kingdom
NHS Liverpool CCG
2 Renshaw Street
Liverpool
L1 2SA
United Kingdom

Sponsor information

Liverpool School of Tropical Medicine
University/education

1 Pembroke Place
Liverpool
L3 5QA
England
United Kingdom

Phone +44 151 705 3100
Email info@lstmed.ac.uk
Website http://www.lstmed.ac.uk/
ROR logo "ROR" https://ror.org/03svjbs84

Funders

Funder type

Government

UK Research and Innovation
Government organisation / National government
Alternative name(s)
UKRI
Location
United Kingdom
Unilever
Government organisation / For-profit companies (industry)
Alternative name(s)
Unilever Global, Unilever PLC, U
Location
United Kingdom

Results and Publications

Intention to publish date30/09/2023
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journel. Dissemination of results amongst local stakeholders.
IPD sharing planData sharing statement to be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 26/07/2023 No No

Editorial Notes

30/03/2022: The ethics approval has been added.
11/01/2022: The CPMS number was added to the protocol/serial no. field.
17/12/2021: Trial's existence confirmed by NHS HRA.