Condition category
Infections and Infestations
Date applied
29/10/2011
Date assigned
21/12/2011
Last edited
22/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sharon Peacock

ORCID ID

Contact details

University of Cambridge
Department of Medicine
Box 157
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 330 528
sharon@tropmedres.ac

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MRSA 001

Study information

Scientific title

Study of MRSA carriage and infection in the United Kingdom: an observational cohort study

Acronym

Study hypothesis

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

Cambridge South Research Ethics Comittee, 24/11/2011

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2012

Overall trial end date

01/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with MRSA colonisation or infection
2. Male or female participents
3. Aged 1 day or above (no upper age limit)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3,300

Participant exclusion criteria

1. No evidence of MRSA colonisation or infection
2. No bacterial isolate available for sequencing

Recruitment start date

01/01/2012

Recruitment end date

01/01/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Cambridge
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

c/o Mr Stephen Kelleher
Research & Development Office
Box 277
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 217 418
stephen.kelleher@addenbrookes.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.cuh.org.uk/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council (MRC) ref: G1000803

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Health Protection Agency (HPA) (UK)

Alternative name(s)

HPA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

NIHR Cambridge Biomedical Research Centre (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

22/03/2016: No publications found, verifying study status with principal investigator