Study of MRSA (Methicillin-resistant Staphylococcus aureus) carriage and infection in the United Kingdom

ISRCTN	ISRCTN51644023
DOI	https://doi.org/10.1186/ISRCTN51644023
Secondary identifying numbers	MRSA 001

Submission date: 29/10/2011
Registration date: 21/12/2011
Last edited: 09/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Staphylococcus aureus is a germ (bacterium) that lives on the skin and in the nose of approximately 30 in 100 people. Methicillin-resistant Staphylococcus aureus (MRSA) is a type of S.aureus that has become resistant to penicillin and similar antibiotics. Over the past few decades the incidence of MRSA infections has increased and certain strains of MRSA have become dominant in hospitals. The UK Department of Health has instituted mandatory surveillance of MRSA blood stream infections (bacteraemias) and this has resulted in a reduction in MRSA bacteraemia. However, MRSA continues to cause a considerable burden of illness and death. One of the problems in controlling MRSA infection is that we do not understand why certain MRSA strains are more successful than others or exactly how they are transmitted between patients and between hospitals. Understanding these factors will help us to identify potential control points for intervention.

Who can participate?
All individuals with MRSA carriage or infection admitted to the study hospitals may participate in the study. Participants may be any age and male or female.

What does the study involve?
We are conducting a study to look at genetic diversity and geographical distribution of MRSA in the UK. This will be achieved by collecting clinical and laboratory information and bacterial isolates from 3,300 patients with MRSA carriage and infection. We are collecting bacterial samples from these patients and performing genetic tests (whole genome sequencing) to determine the genetic differences between strains. We are examining patient movements within a hospital and between hospitals in the UK. By combining this information we hope to learn more about genetic differences in MRSA and transmission pathways. All clinical data and bacterial samples are being collected as part of routine clinical care. There are no study-specific interventions although all patients will receive treatment for MRSA colonisation or infection as part of routine clinical care.

What are the possible benefits and risks of participating?
There are no benefits to the individual patient in taking part. However, information that is obtained from the study may help to inform local infection control practices and public health policy. The risks of participation are negligible as no additional samples will be taken and no additional procedures will be performed.

Where is the study run from?
The study is being conducted by the University of Cambridge. The lead site will be the Cambridge University Hospitals NHS Foundation Trust and additional sites have been identified in England. Bacterial isolates are being sequenced at the Wellcome Trust Sanger Institute.

When is the study starting and how long is it expected to run for?
The study started in April 2012 and is expected to run for 2 years.

Who is funding the study?
The study is being funded by UK Clinical Research Collaboration (UKCRC) Translational Infection Research Initiative, the Health Protection Agency and the NIHR Cambridge Biomedical Research Centre (UK).

Who is the main contact?
Professor Sharon Peacock
sharon@tropmedres.ac

Contact information

Prof Sharon Peacock
Scientific

University of Cambridge
Department of Medicine
Box 157
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Phone	+44 (0)1223 330 528
Email	sharon@tropmedres.ac

Study information

Study design	Observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Study of MRSA carriage and infection in the United Kingdom: an observational cohort study
Study objectives	1. Can we use bacterial whole genome sequencing to determine MRSA phylogeography and transmission pathways in the United Kingdom? 2. Can we use phenotypic drug susceptibility (antibiograms) to track MRSA transmission within hospitals? 3. What are the relationships between clinical features, bacterial phenotype, and bacterial genotype in patients with MRSA carriage and infection in the UK?
Ethics approval(s)	Cambridge South Research Ethics Comittee, 24/11/2011
Health condition(s) or problem(s) studied	Methicillin-resistant Staphylococcus aureus (MRSA)
Intervention	Observational cohort study of patients with MRSA infection or colonisation hospitals in the United Kingdom. There are no study-specific interventions although all patients will receive treatment for MRSA colonisation or infection as required
Intervention type	Other
Primary outcome measure	1. Baseline clinical and demographic information 2. Outcome at hospital discharge 3. Antibiotic resistance profiles 4. Bacterial sequence data
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/01/2012
Completion date	01/01/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	3,300
Key inclusion criteria	1. Patients with MRSA colonisation or infection 2. Male or female participents 3. Aged 1 day or above (no upper age limit)
Key exclusion criteria	1. No evidence of MRSA colonisation or infection 2. No bacterial isolate available for sequencing
Date of first enrolment	01/01/2012
Date of final enrolment	01/01/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Cambridge

Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Mr Stephen Kelleher
Research & Development Office
Box 277
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Phone	+44 (0)1223 217 418
Email	stephen.kelleher@addenbrookes.nhs.uk
Website	http://www.cuh.org.uk/
"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Government

UK Clinical Research Collaboration (UKCRC) Translational Infection Research Initiative (TIRI)

No information available

Medical Research Council (MRC) ref: G1000803
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Health Protection Agency (HPA) (UK)
Government organisation / National government

Alternative name(s): HPA
Location: United Kingdom

NIHR Cambridge Biomedical Research Centre (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Participant level data are not available. The whole genome sequences from this study have been deposited in the European Nucleotide Archive (https://www.ebi.ac.uk/ena) under study accession number PRJEB3174.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/10/2017		Yes	No

Editorial Notes

09/05/2018: Publication reference and IPD sharing statement added.
27/04/2018: No publications found, verifying study status with principal investigator.
22/03/2016: No publications found, verifying study status with principal investigator.