Back to resultsControl of MRSA in Nursing Homes: Decolonization vs Standard Precautions
Primary Purpose
Methicillin-Resistant Staphylococcus Aureus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intervention
Sponsored by
About this trial
This is an interventional prevention trial for Methicillin-Resistant Staphylococcus Aureus focused on measuring Methicillin-Resistant Staphylococcus aureus, Decolonisation, Nursing homes, Infection Control
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Standard Precautions
Intervention
Arm Description
control arm, standards precautions for all residents living in the nursing home of control arm, including MRSA carriers
Intervention arm, standards precautions for all residents living in nursing homes of intervention arm, and topical decolonization for MRSA carriers, including environmental disinfection
Outcomes
Primary Outcome Measures
To determine the change in prevalence of MRSA carriage among residents of each Nursing homes group at the end of the one study 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
Secondary Outcome Measures
To determine the effectiveness of the reinforced strategy to prevent MRSA infection, compared to the standard strategy
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.
Full Information
NCT ID
NCT01138462
First Posted
June 4, 2010
Last Updated
March 26, 2020
Sponsor
University of Lausanne Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT01138462
Brief Title
Control of MRSA in Nursing Homes: Decolonization vs Standard Precautions
Official Title
Universal Screening and Decolonization vs Standard Precautions for Control of Methicillin-resistant Staphylococcus Aureus (MRSA) in Nursing Homes: a Cluster, Randomised Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the better approach between the currently procedure (i.e. standards precautions) and a reinforced strategy to control MRSA transmission in the institutionalized population of nursing homes in Canton of Vaud, Switzerland.
Detailed Description
MRSA carriage among nursing homes residents of Canton Vaud, Switzerland, is increasing, despite use of standard precautions. Recommendation to prevent MRSA transmission in long term care facilities are lacking. We aim to reinforce the current infection control strategy by general MRSA screening of institutionalised residents and decolonisation of MRSA carriers. Because the uncertainties in the impact of this reinforced strategy, we aim to compare this action to the policy actually applied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methicillin-Resistant Staphylococcus Aureus
Keywords
Methicillin-Resistant Staphylococcus aureus, Decolonisation, Nursing homes, Infection Control
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Precautions
Arm Type
No Intervention
Arm Description
control arm, standards precautions for all residents living in the nursing home of control arm, including MRSA carriers
Arm Title
Intervention
Arm Type
Other
Arm Description
Intervention arm, standards precautions for all residents living in nursing homes of intervention arm, and topical decolonization for MRSA carriers, including environmental disinfection
Intervention Type
Other
Intervention Name(s)
intervention
Other Intervention Name(s)
topical MRSA decolonisation and environmental disinfection
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine the change in prevalence of MRSA carriage among residents of each Nursing homes group at the end of the one study year
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To determine the effectiveness of the reinforced strategy to prevent MRSA infection, compared to the standard strategy
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgio Zanetti, MD
Organizational Affiliation
University Hospital of Lausanne, Switzerland
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
25782894
Citation
Bellini C, Petignat C, Masserey E, Bula C, Burnand B, Rousson V, Blanc DS, Zanetti G. Universal screening and decolonization for control of MRSA in nursing homes: a cluster randomized controlled study. Infect Control Hosp Epidemiol. 2015 Apr;36(4):401-8. doi: 10.1017/ice.2014.74.
Results Reference
background
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Control of MRSA in Nursing Homes: Decolonization vs Standard Precautions
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