|
ISRCTN
|
ISRCTN75590122
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
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
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
RJ1 05/0083
|
|
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)
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
MRSA colonisation (infection and bacteraemia)
|
|
Participants - inclusion criteria
|
All patients admitted to 10 study wards in the duration of the study.
|
|
Participants - exclusion criteria
|
Patients not wishing to participate in the study.
|
|
Anticipated start date
|
01/01/2006
|
|
Anticipated end date
|
01/04/2007
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Approximately 15,000
|
|
Interventions
|
The use of a rapid method in detecting MRSA. This will be compared against the currently employed non-rapid method of detection.
|
|
Primary outcome measure(s)
|
Ward MRSA transmission rates.
|
|
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
|
|
Sources of funding
|
Department of Health (UK) (ref: 0190016)
|
|
Trial website
|
|
|
Publications
|
Results in http://www.ncbi.nlm.nih.gov/pubmed/18417521
|
|
Contact name
|
Prof
Gary
French
|
|
Address
|
Department of Infection
5th Floor North Wing
St.Thomas' Hospital
Lambeth Palace Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE1 7EH
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Guy's and St.Thomas' NHS Foundation Trust (UK)
|
|
Address
|
Dr. Kate Blake
West Wing
Guy's Hospital
St. Thomas' Street
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE1 9RT
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.guysandstthomas.nhs.uk
|
|
Date applied
|
07/11/2005
|
|
Last edited
|
18/04/2008
|
|
Date ISRCTN assigned
|
10/01/2006
|
