Back to resultsComprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus (MRSA) in the Outpatient Setting
Primary Purpose
Methicillin-resistant Staphylococcus Aureus
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
pharmacological decolonization treatment
Education
Sponsored by
About this trial
This is an interventional treatment trial for Methicillin-resistant Staphylococcus Aureus focused on measuring methicillin-resistant Staphylococcus aureus, decolonization, random allocation, outpatient
Eligibility Criteria
Inclusion Criteria:
- Prior MRSA infection (i.e index case)
- Identified as being colonized with MRSA on initial screen
Exclusion Criteria:
- Are pregnant or breastfeeding.
- Have indwelling catheters.
- Received prior decolonization treatment within last 6 months of enrollment.
- Have allergy to study medication.
- Are colonized with MRSA strain resistant to study medication.
- Have active infection requiring systemic antimicrobials.
- Are household contacts to index case.
Sites / Locations
- Foothills Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
decolonization treatment
education
Arm Description
topical antiseptic, intranasal antimicrobial, and oral antimicrobial that have activity against MRSA in addition to education regarding personal hygiene and environmental cleaning
No decolonization treatment in addition to education regarding personal hygiene and environmental cleaning
Outcomes
Primary Outcome Measures
Eradication of MRSA carriage
Secondary Outcome Measures
Occurrence of MRSA infection
Full Information
NCT ID
NCT01232231
First Posted
November 1, 2010
Last Updated
February 14, 2013
Sponsor
Joseph Kim
Collaborators
Alberta Health services
1. Study Identification
Unique Protocol Identification Number
NCT01232231
Brief Title
Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus (MRSA) in the Outpatient Setting
Official Title
Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus in the Outpatient Setting: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph Kim
Collaborators
Alberta Health services
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of topical and oral antibiotics in eliminating carriage of methicillin-resistant Staphylococcus aureus (MRSA) among those living in the community. We hypothesize that a greater proportion of those who receive intervention will eliminate MRSA carriage compared to those who do not receive any intervention.
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, decolonization, random allocation, outpatient
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
decolonization treatment
Arm Type
Active Comparator
Arm Description
topical antiseptic, intranasal antimicrobial, and oral antimicrobial that have activity against MRSA in addition to education regarding personal hygiene and environmental cleaning
Arm Title
education
Arm Type
Other
Arm Description
No decolonization treatment in addition to education regarding personal hygiene and environmental cleaning
Intervention Type
Drug
Intervention Name(s)
pharmacological decolonization treatment
Intervention Description
Chlorhexidine gluconate 4% body scrub and 2% shampoo daily PLUS mupirocin 2%, fusidic acid 2%, or chlorhexidine gluconate 0.2% intranasally bid PLUS trimethoprim-sulfamethoxazole 160/800mg po bid or doxycycline 100mg po bid all for 7 days
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
No pharmacological decolonization treatment but given education regarding personal hygiene and environmental cleaning
Primary Outcome Measure Information:
Title
Eradication of MRSA carriage
Time Frame
90 days after randomization
Secondary Outcome Measure Information:
Title
Occurrence of MRSA infection
Time Frame
Within 6 months of randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Prior MRSA infection (i.e index case)
Identified as being colonized with MRSA on initial screen
Exclusion Criteria:
Are pregnant or breastfeeding.
Have indwelling catheters.
Received prior decolonization treatment within last 6 months of enrollment.
Have allergy to study medication.
Are colonized with MRSA strain resistant to study medication.
Have active infection requiring systemic antimicrobials.
Are household contacts to index case.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Louie, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus (MRSA) in the Outpatient Setting
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