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?
Kings 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
Kings 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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/27658666