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
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

Department of Infection
5th Floor North Wing
St.Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Study information

Study designA randomised, controlled crossover trial (non-blinded)
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Scientific title
Study objectivesThere 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) studiedMRSA colonisation (infection and bacteraemia)
InterventionThe use of a rapid method in detecting MRSA. This will be compared against the currently employed non-rapid method of detection.
Intervention typeOther
Primary outcome measureWard MRSA transmission rates.
Secondary outcome measures1. 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 date01/01/2006
Completion date01/04/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsApproximately 15,000
Key inclusion criteriaAll patients admitted to 10 study wards in the duration of the study.
Key exclusion criteriaPatients not wishing to participate in the study.
Date of first enrolment01/01/2006
Date of final enrolment01/04/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Infection
London
SE1 7EH
United Kingdom

Sponsor information

Guy's and St.Thomas' NHS Foundation Trust (UK)
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
ROR logo "ROR" https://ror.org/00j161312

Funders

Funder type

Government

Department of Health (UK) (ref: 0190016)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 26/04/2008 Yes No