Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000322437
Ethics application status
Approved
Date submitted
7/06/2007
Date registered
18/06/2007
Date last updated
18/06/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Do rapid detection & isolation of colonised patients reduce Methicillin-Resistant Staphylococcus Aureus (MRSA) spread? An epidemiological, economic & modelling study.
Scientific title
Does rapid detection and isolation with use of contact precautions for MRSA colonised intensive care unit patients result in decreased transmission of MRSA compared with no active screening and use of standard precautions?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nosocomial acquisition of MRSA 1868 0
Condition category
Condition code
Infection 1965 1965 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: All patients admitted to the ICU during this time period will undergo active screening with rapid molecular detection of MRSA on admission to, discharge from and twice weekly during the ICU stay. Patients found to be colonised with MRSA will be isolated in a single room (or cohorted with other MRSA colonised patients). Contact precautions (gloves and gowns for all contacts) will also be used for MRSA colonised patients. These precautions will be used for the duration of the patient's ICU stay once found to be colonised. Patients not found to be colonised will be managed using the same infection control precautions as in the control period (ie standard precautions and plastic aprons for all patients).
Intervention code [1] 1809 0
Other interventions
Comparator / control treatment
Control group: usual practice ie use of Standard Precautions (including wearing plastic aprons for all contacts) for patients regardless of MRSA colonisation status. These precautions will be used for the duration of the patient's stay in the intensive care unit (ICU). Other infection control precautions will be used as indicated for other conditions.
Control group
Historical

Outcomes
Primary outcome [1] 2779 0
Acquisition of MRSA at any time during ICU admission. Patients will required documented evidence of negative screening swabs and then subsequent MRSA positive screening swabs or clinical isolates to be defined as an MRSA acquisition.
Timepoint [1] 2779 0
Results of swabs will be monitored daily.
Secondary outcome [1] 4690 0
Proportion of patients with new clinical isolate of MRSA.
Timepoint [1] 4690 0
At any time during ICU admission and for 48 hours after ICU discharge.
Secondary outcome [2] 4691 0
Results of swabs.
Timepoint [2] 4691 0
Will be monitored daily
Secondary outcome [3] 4692 0
Patients who have had MRSA colonisation in the ICU.
Timepoint [3] 4692 0
Will be monitored for development of clinical infection up to the time of hospital discharge

Eligibility
Key inclusion criteria
All patients admitted to the Royal Melbourne Hospital (adult) ICU
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Prospectice interrupted time series design ie before and after study.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2103 0
Government body
Name [1] 2103 0
National Health & Medical Research Council (NH&MRC)
Country [1] 2103 0
Australia
Funding source category [2] 2104 0
Government body
Name [2] 2104 0
Department of Human Services
Country [2] 2104 0
Australia
Funding source category [3] 2105 0
Charities/Societies/Foundations
Name [3] 2105 0
Sylvia and Charles Viertel Clinical Investigatorship
Country [3] 2105 0
Australia
Primary sponsor type
Individual
Name
Caroline Marshall
Address
Country
Secondary sponsor category [1] 1912 0
None
Name [1] 1912 0
Not applicable
Address [1] 1912 0
Country [1] 1912 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3896 0
Melbourne Health Human Research and Ethics Committee-Royal Melbourne Hospital
Ethics committee address [1] 3896 0
Ethics committee country [1] 3896 0
Australia
Date submitted for ethics approval [1] 3896 0
Approval date [1] 3896 0
21/02/2007
Ethics approval number [1] 3896 0
2006.256

Summary
Brief summary
MRSA is a significant problem for hospital patients, causing increased length of stay and risk of complications. It is spread mainly on the contaminated hands of healthcare workers. Control of MRSA within hospitals still remains controversial, with some insisting that swabbing of all patients and use of special isolation precautions is mandatory for prevention of its spread. We plan to test whether swabbing all patients admitted to the intensive care unit and then putting patients who are found to be positive in single rooms and using gloves and gowns for all contact with these patients is more effective at preventing spread of MRSA from patient to patient than what we currently do ie looking after patients in the general ward, wearing plastic aprons at all times and only using gowns and gloves if we are likely to come into contact with bodily fluids (and not swabbing any patients). We plan to use the most rapid tests available to determine whether someone is carrying MRSA on their body which will give us a result within hours compared with the 2-3 days it currently takes to get a result. We also plan to do an economic evaluation to see if the intervention is worth the extra cost.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27912 0
Address 27912 0
Country 27912 0
Phone 27912 0
Fax 27912 0
Email 27912 0
Contact person for public queries
Name 10998 0
Caroline Marshall
Address 10998 0
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 10998 0
Australia
Phone 10998 0
+61 3 93427212
Fax 10998 0
Email 10998 0
caroline.marshall@mh.org.au
Contact person for scientific queries
Name 1926 0
Caroline Marshall
Address 1926 0
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 1926 0
Australia
Phone 1926 0
+61 3 93427212
Fax 1926 0
Email 1926 0
caroline.marshall@mh.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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