Condition category
Infections and Infestations
Date applied
20/06/2014
Date assigned
31/07/2014
Last edited
31/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
MRSA is a type of bacterial infection that is resistant to a number of widely used antibiotics. This means that it tends to be more difficult to treat than other bacterial infections. All patients admitted to a NHS hospital are tested for MRSA. Those patients found to be carriers are placed on the MRSA care pathway, which typically involves being placed in an isolation room in order to try and prevent the bacteria spreading to other patients and then treated by antibiotics to try and stop them developing an active infection. MRSA infection can be detected using a conventional culture method or via a polymerase chain reaction (PCR) based method. The PCR method gives faster results than the culture method, so, as the infected patient is placed on the MRSA pathway more quickly, one might expect the number of other patients that are then infected would be fewer compared to using the culture method. However, research into this has had mixed results with some showing no significant reduction at all. This may be due to the time needed to take the specimen to the laboratory in order to do the PCR. Point of care (POC) tests are performed in the wards by ward staff, such as nurses. This means that there is no time wasted by having to take the specimen to the laboratory. Here, we investigate whether using a POC PCR-based test will lead to a reduction of the spread of MRSA and infection rates when compared to a conventional culture based method.

Who can participate?
All adults patients admitted to one of the wards taking part in the study can participate.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in the control group are swabbed for MRSA at admission and these swabs are taken to the laboratory for MRSA testing using conventional culture methods. Those in the treatment group have one set of swabs taken for conventional culture MRSA testing and one taken for POC PCR-based MRSA testing in the ward. All participants in both groups are swabbed again for MRSA infection as they are discharged. Any patient found to carriers or are infected are placed on the MRSA care pathway.

What are the possible benefits and risks of participating?
By identifying MRSA carriers rapidly, those with MRSA can be more quickly placed on the MRSA care pathway. This means that the study may reduce the chance of the infection spreading or the carrier developing an infection. The risks are minimal as MRSA swabbing is carried out already without adverse effect.

Where is the study run from?
King’s College Hospital, London (UK)

When is the study starting and how long is it expected to run for?
May 2011 to July 2012.

Who is funding the study?
Department of Health, England (UK)

Who is the main contact?
Dr Peijun Wu,
Peijun.wu@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dakshika Jeyaratnam

ORCID ID

Contact details

Department of Medical Microbiology
King’s College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0) 203 299 2569
d.jeyaratnam@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A trial of a rapid point of care (POC) method of MRSA detection

Acronym

Study hypothesis

Point of care (POC) tests eliminate the need for transportation of specimens to a laboratory and they can be performed by ward staff (for example, nursing staff) at any time of day or night and do not have to be batched. Thus POC PCR-based tests should have a turn around time of as little as 70 minutes between sampling and result and should deliver the theoretical advantages of truly rapid screening. If these tests are performed on patients on admission to wards, the patients’ MRSA status will be known and they will be placed on the MRSA care pathway.

Ethics approval

National Research Ethics Service, 13/10/2009, ref. 09/H0709/68

Study design

It is a cluster-randomised, controlled crossover (two phases) trial design. After the first phase, the wards swap between the control arm and intervention arm for the second phase.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

MRSA infection

Intervention

Control group: When each patient is admitted to and discharged from the ward, nursing staff will take a set of MRSA screening swabs. MRSA screening on admission is already in practice at King's College Hospital NHS foundation Trust (KCH). Nursing staff take swabs from nose, throat, perineum, skin breaks and other clinically indicated sites as per the current procedure, and send the swabs to the laboratory for MRSA detection by conventional culture methods.
Treatment group: Nursing staff will take a set of MRSA screening swabs and using a double headed swab for nose. Nursing staff will use one of doubled swab heads for POCT using the Cepheid Xpert MRSA system on the ward, and send the other swabs to the laboratory for MRSA detection using conventional culture methods.

Nursing staff will swab patients on discharge from the ward at both control arm and treatment arm. During the study, the patient will be managed as per the Trust MRSA Care Pathway. Nursing staff will manage the patient identified as MRSA positive by either POCT or culture method as per the Trust MRSA Care Pathway.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

MRSA transmission rates = the ratio of patients who are positive for MRSA by conventional microbiological method at the time of admission to the number of patients who are negative for MRSA on admission screens by conventional microbiological method and subsequently become positive by discharge on any specimen taken >48 hours after admission.

The primary outcome will be analysed using generalised estimating equations with Poisson family, log link and robust standard errors will be used to fully account for correlations of observations made within wards, periods and ward periods.

Secondary outcome measures

1. Appropriate and inappropriate isolation days
2. MRSA carriage rate and acquisition rate

Secondary outcomes will be measured after one month.

Overall trial start date

03/05/2011

Overall trial end date

31/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

All adult admissions to study wards who are screened within 48 hours of admission to and discharge from the study wards are eligible for inclusion.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10,000

Participant exclusion criteria

Patients who are:
1. MRSA positive on any specimens taken up to 5 days before the current admission
2. MRSA culture positive on study ward MRSA admission screen
3. Are not swabbed for MRSA on admission
4. Have MRSA admission screening swabs taken >48 hours after study ward admission
5. MRSA discharge screens which do not contain nose, throat and groin or perineum swabs
6. Are not swabbed for MRSA on discharge

Recruitment start date

03/05/2011

Recruitment end date

31/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Medical Microbiology
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

Guy's & St Thomas' NHS Foundation Trust (UK)

Sponsor details

c/o Karen Ignatian
Guy's & St Thomas' NHS Foundation Trust
2nd Floor Conybeare House
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
+44 (0) 207 188 5736
karen.ignatian@GSTT.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Department of Health, England (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