Condition category
Infections and Infestations
Date applied
24/04/2008
Date assigned
30/07/2008
Last edited
22/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Hawkey

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

M0005186425

Study information

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

Acronym

EMMS

Study hypothesis

Early identification of patients colonised with methicillin-resistant Staphylococcus aureus (MRSA) using rapid methods alone reduces transmission.

Ethics approval

Ethics approval received from the East Birmingham Ethics Committee on the 17th August 2005 (ref: 05/Q2703/62).

Study design

A prospective, cluster, two period cross-over design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

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, l’Etoile, 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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/10/2005

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12,000

Participant exclusion criteria

Patients less than 18 years of age

Recruitment start date

01/10/2005

Recruitment end date

01/07/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

West Midlands Public Health Laboratory
Birmingham
B9 5SS
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Skipton House
80 London Road
London
SE1 6LH
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Policy Research Program (PRP) (ref: 0190014)

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

1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17915008
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19622077

Publication citations

  1. Protocol

    Hardy KJ, Szczepura A, Davies R, Bradbury A, Stallard N, Gossain S, Walley P, Hawkey PM, A study of the efficacy and cost-effectiveness of MRSA screening and monitoring on surgical wards using a new, rapid molecular test (EMMS)., BMC Health Serv Res, 2007, 7, 160, doi: 10.1186/1472-6963-7-160.

  2. Results

    Hardy K, Price C, Szczepura A, Gossain S, Davies R, Stallard N, Shabir S, McMurray C, Bradbury A, Hawkey PM, Reduction in the rate of methicillin-resistant Staphylococcus aureus acquisition in surgical wards by rapid screening for colonization: a prospective, cross-over study., Clin. Microbiol. Infect., 2010, 16, 4, 333-339, doi: 10.1111/j.1469-0691.2009.02899.x.

Additional files

Editorial Notes