The evaluation of rapid methicillin-resistant Staphylococcus aureus (MRSA) screening

ISRCTN	ISRCTN84432505
DOI	https://doi.org/10.1186/ISRCTN84432505
Protocol serial number	M0005186425
Sponsor	Department of Health (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Policy Research Program (PRP) (ref: 0190014)

Submission date: 24/04/2008
Registration date: 30/07/2008
Last edited: 22/03/2010

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 Peter Hawkey
Scientific

West Midlands Public Health Laboratory
Heart of England NHS Foundation Trust
Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Study information

Primary study design	Interventional
Study design	A prospective, cluster, two period cross-over design
Secondary study design	Randomised controlled trial
Scientific title	A study of the efficacy and cost-effectiveness of methicillin-resistant Staphylococcus aureus (MRSA) screening and monitoring on surgical wards using a new, rapid molecular test
Study acronym	EMMS
Study objectives	Early identification of patients colonised with methicillin-resistant Staphylococcus aureus (MRSA) using rapid methods alone reduces transmission.
Ethics approval(s)	Ethics approval received from the East Birmingham Ethics Committee on the 17th August 2005 (ref: 05/Q2703/62).
Health condition(s) or problem(s) studied	Methicillin-resistant Staphylococcus aureus (MRSA) colonisation and infection
Intervention	This is a prospective, cluster two-period cross-over design, with the only difference between the two periods being the method of MRSA detection. The study compares the use of rapid MRSA testing with the BD GeneOhm™ molecular test (BD Diagnostics - GeneOhm, CA, USA) with a standard direct inoculation culture method using chromogenic media (Biomerieux, Marcy, lEtoile, France). Wards were assigned to one of two groups, with similar wards being placed in opposite groups. The study consists of two eight-month cross-over periods, with one month follow up of study patients at the end of the final period. For the first eight month period four wards use rapid testing and standard culture methods and three wards use only standard culture methods, this is then reversed for the second eight month period. All patients are screened on admission to the ward and then every four days using a nasal swab. There was no patient follow up on discharge from the study wards.
Intervention type	Other
Primary outcome measure(s)	1. MRSA transmission rates 2. MRSA infection rates 3. Antibiotic prescribing levels 4. MRSA related morbidity 5. Test replicability, reliability, sensitivity/specificity, predictive positive value (PPV), negative predictive value (NPV), laboratory turn-around time
Key secondary outcome measure(s)	1. Cost of hospital episode for all patients 2. Post-discharge primary/community care costs and any subsequent admissions for MRSA positives 3. Length of stay/intensive care unit (ITU) episodes for all patients 4. Recovery/rehabilitation period for MRSA positives
Completion date	01/07/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	12000
Key inclusion criteria	1. Patients greater than 18 years of age, either sex 2. Admitted to seven surgical wards at Heart of England NHS Foundation Trust
Key exclusion criteria	Patients less than 18 years of age
Date of first enrolment	01/10/2005
Date of final enrolment	01/07/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

West Midlands Public Health Laboratory

Birmingham
B9 5SS
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	01/04/2010		Yes	No
Protocol article	protocol	03/10/2007		Yes	No