- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01138462
Control of MRSA in Nursing Homes: Decolonization vs Standard Precautions
Universal Screening and Decolonization vs Standard Precautions for Control of Methicillin-resistant Staphylococcus Aureus (MRSA) in Nursing Homes: a Cluster, Randomised Controlled Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- all nursing homes of canton Vaud, Switzerland, that give the consent of participation
Exclusion Criteria:
- refusal to participate
Inclusion criteria for decolonisation in intervention nursing homes:
- all MRSA positive residents living in a Nursing Home included in the intervention group
Exclusion Criteria for decolonisation:
- residents that refuse to be screened or refused the decolonisation
- life expectancy shorter of 7 days
- known intolerance of disinfectant/ topical antibiotics used in the protocol
- active MRSA infection
- asymptomatic MRSA bacteriuria
- stage IV wound (according to National Pressure Ulcer Advisory Panel)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Standard Precautions
control arm, standards precautions for all residents living in the nursing home of control arm, including MRSA carriers
|
|
OTHER: Intervention
Intervention arm, standards precautions for all residents living in nursing homes of intervention arm, and topical decolonization for MRSA carriers, including environmental disinfection
|
5 days topical decolonisation including nasal mupirocin tid, chlorhexidine mouth wash tid, chlorhexidine body wash once daily. Daily direct resident's environmental disinfection during decolonisation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the change in prevalence of MRSA carriage among residents of each Nursing homes group at the end of the one study year
Time Frame: 1 year
|
in each control and intervention nursing home: MRSA screening of all residents of nursing homes of Canton Vaud, at baseline and 1 year later, in order to compare MRSA prevalence changes at nursing homes levels
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the effectiveness of the reinforced strategy to prevent MRSA infection, compared to the standard strategy
Time Frame: 1 year
|
In a subpopulation of all nursing homes residents (10% of the whole population), recording of all microbiologically documented MRSA infection, according to nosocomial infection definitions of the Center of Diseases Control (CDC) of Atlanta.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Giorgio Zanetti, MD, University Hospital of Lausanne, Switzerland
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocole 96/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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