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 |
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DOI | https://doi.org/10.1186/ISRCTN75590122 |
Secondary identifying numbers | RJ1 05/0083 |
- 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
Scientific
Department of Infection
5th Floor North Wing
St.Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
Study information
Study design | A randomised, controlled crossover trial (non-blinded) |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Screening |
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 | 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 study start date | 01/01/2006 |
Completion date | 01/04/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | Approximately 15,000 |
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
- England
- United Kingdom
Study participating centre
Department of Infection
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Guy's and St.Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Dr. Kate Blake
West Wing
Guy's Hospital
St. Thomas' Street
London
SE1 9RT
England
United Kingdom
Website | http://www.guysandstthomas.nhs.uk |
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https://ror.org/00j161312 |
Funders
Funder type
Government
Department of Health (UK) (ref: 0190016)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 26/04/2008 | Yes | No |