A randomised crossover trial of a new, rapid method of detecting methicillin-resistant Staphylococcus aureus (MRSA) and comparing against conventional screening: in terms of the efficacy and the effect upon hospital methicillin-resistant Staphylococcus aureus infection rates, transmission rates and the use of hospital resources

ISRCTN	ISRCTN75590122
DOI	https://doi.org/10.1186/ISRCTN75590122
Protocol serial number	RJ1 05/0083
Sponsor	Guy's and St.Thomas' NHS Foundation Trust (UK)
Funder	Department of Health (UK) (ref: 0190016)

Submission date: 07/11/2005
Registration date: 10/01/2006
Last edited: 18/04/2008

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

Not provided at time of registration

Contact information

Prof Gary French
Scientific

Department of Infection
5th Floor North Wing
St.Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Study information

Primary study design	Interventional
Study design	A randomised, controlled crossover trial (non-blinded)
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	There is an assumption, which has not been tested, that quicker detection of methicillin-resistant Staphylococcus aureus (MRSA) carriers will lead to lower transmission within hospitals. Technology to obtain results more rapidly is being developed. Currently a new, polymerase chain reaction (PCR) based method of MRSA detection provides a screening tool that is much faster but also more expensive than standard methods. We propose to investigate whether significantly faster detection of MRSA cases does lead to reduction in transmission and other adverse outcomes by means of a randomised, crossover trial on both medical and surgical wards.
Ethics approval(s)	Ethics approval received from the local medical ethics committee (ref: 05/Q0702/157)
Health condition(s) or problem(s) studied	MRSA colonisation (infection and bacteraemia)
Intervention	The use of a rapid method in detecting MRSA. This will be compared against the currently employed non-rapid method of detection.
Intervention type	Other
Primary outcome measure(s)	Ward MRSA transmission rates.
Key secondary outcome measure(s)	1. Ward MRSA bacteraemia rates 2. Ward MRSA clinical infection rates 3. Length of hospital stay 4. Use of isolation facilities 5. MRSA-related nursing workload 6. Rapid test sensitivity, specificity, positive predictive value, negative predictive value, turn around time and cost with the conventional method using screening swabs taken under routine conditions 7. Economic analysis
Completion date	01/04/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	15000
Key inclusion criteria	All patients admitted to 10 study wards in the duration of the study.
Key exclusion criteria	Patients not wishing to participate in the study.
Date of first enrolment	01/01/2006
Date of final enrolment	01/04/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Infection

London
SE1 7EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	26/04/2008		Yes	No