Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RJ1 05/0083
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the local medical ethics committee (ref: 05/Q0702/157)
Study design
A randomised, controlled crossover trial (non-blinded)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Ward MRSA transmission rates.
Secondary outcome measures
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
Overall trial start date
01/01/2006
Overall trial end date
01/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients admitted to 10 study wards in the duration of the study.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Approximately 15,000
Participant exclusion criteria
Patients not wishing to participate in the study.
Recruitment start date
01/01/2006
Recruitment end date
01/04/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Infection
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's and St.Thomas' NHS Foundation Trust (UK)
Sponsor details
Dr. Kate Blake
West Wing
Guy's Hospital
St. Thomas' Street
London
SE1 9RT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Department of Health (UK) (ref: 0190016)
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/18417521
Publication citations
-
Results
Jeyaratnam D, Whitty CJ, Phillips K, Liu D, Orezzi C, Ajoku U, French GL, Impact of rapid screening tests on acquisition of meticillin resistant Staphylococcus aureus: cluster randomised crossover trial., BMJ, 2008, 336, 7650, 927-930, doi: 10.1136/bmj.39525.579063.BE.