Randomized Controlled Trial of Standard Versus Systemic Decolonization Therapy for the Eradication of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
Primary Purpose
Methicillin-resistant Staphylococcus Aureus
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rifampin
Doxycycline
2% mupirocin ointment
4% chlorhexidine gluconate
Sponsored by
About this trial
This is an interventional treatment trial for Methicillin-resistant Staphylococcus Aureus focused on measuring MRSA, doxycycline, rifampin, mupirocin, chlorhexidine gluconate, decolonization, methicillin-resistant staphylococcus aureus
Eligibility Criteria
Inclusion Criteria:
- Any patient colonized with MRSA
Exclusion Criteria:
- Currently on treatment with antibiotics
- Pregnant or breastfeeding women
- Active infection
- Hepatic cirrhosis or abnormal INR due to liver disease
- Decolonization in the previous two (2) months
- MRSA bacteria resistant to one or more of the study medications
- AST and ALT levels more than five times the upper limit of normal.
Sites / Locations
- Saint John Regional Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Systemic decolonization
Standard decolonization
Arm Description
7-day course of 4% chlorhexidine gluconate daily washes and 2% mupirocin ointment to the anterior nares twice daily in addition to oral rifampin (600mg daily), and doxycycline (100mg twice daily)
7-day course of 2% mupirocin ointment to the anterior nares twice daily and 4% chlorhexidine gluconate washes once per day.
Outcomes
Primary Outcome Measures
Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months
To compare standard versus systemic decolonization for their ability to sustain MRSA decolonization up to one year post-decolonization.
Secondary Outcome Measures
Changes in susceptibility patterns of MRSA isolates.
Study isolates will be evaluated with regards to mupirocin, rifampin and tetracycline resistance patterns, where individuals remain colonized, or re-colonize subsequent to implementation of the decolonization protocol.
Full Information
NCT ID
NCT01438515
First Posted
September 21, 2011
Last Updated
February 12, 2020
Sponsor
Horizon Health Network
1. Study Identification
Unique Protocol Identification Number
NCT01438515
Brief Title
Randomized Controlled Trial of Standard Versus Systemic Decolonization Therapy for the Eradication of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
Official Title
Randomized Controlled Trial of Chlorhexidine Gluconate, Intranasal Mupirocin, Rifampin and Doxycycline Versus Chlorhexidine Gluconate and Intranasal Mupirocin Alone for the Eradication of Methicillin-resistant Staphylococcus Aureus Among an Ambulatory Patient Population
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Horizon Health Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
MRSA decolonization may reduce the risk of subsequent MRSA infection and further transmission. A recent randomized controlled trial demonstrated that systemic decolonization may be safe and effective among hospitalized patients when compared to no treatment. As a large number of the investigators patients require re-admission and further transmission may take place in the community, the investigators are comparing the standard decolonization protocol for MRSA eradication to the systemic decolonization protocol among an ambulatory population.
Standard decolonization protocols, which use only topical agents, are limited in efficacy. The method of systemic decolonization to be studied here appears to have greater efficacy than the standard approach using only topical agents. However, concerns have been raised that the increased use of systemic antibiotics may lead to increased levels of drug resistance adverse effects, without sustained decolonization. This study seeks to provide further data to help answer these questions and provide guidance for further policy development and implementation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methicillin-resistant Staphylococcus Aureus
Keywords
MRSA, doxycycline, rifampin, mupirocin, chlorhexidine gluconate, decolonization, methicillin-resistant staphylococcus aureus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systemic decolonization
Arm Type
Experimental
Arm Description
7-day course of 4% chlorhexidine gluconate daily washes and 2% mupirocin ointment to the anterior nares twice daily in addition to oral rifampin (600mg daily), and doxycycline (100mg twice daily)
Arm Title
Standard decolonization
Arm Type
Active Comparator
Arm Description
7-day course of 2% mupirocin ointment to the anterior nares twice daily and 4% chlorhexidine gluconate washes once per day.
Intervention Type
Drug
Intervention Name(s)
Rifampin
Intervention Description
600mg po once daily x 7 days
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
100mg po twice daily x 7 days
Intervention Type
Other
Intervention Name(s)
2% mupirocin ointment
Intervention Description
~ 1cm applied to the anterior nares twice daily for 7 days
Intervention Type
Other
Intervention Name(s)
4% chlorhexidine gluconate
Intervention Description
Daily full body wash (including hair) for 7 days
Primary Outcome Measure Information:
Title
Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months
Description
To compare standard versus systemic decolonization for their ability to sustain MRSA decolonization up to one year post-decolonization.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in susceptibility patterns of MRSA isolates.
Description
Study isolates will be evaluated with regards to mupirocin, rifampin and tetracycline resistance patterns, where individuals remain colonized, or re-colonize subsequent to implementation of the decolonization protocol.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient colonized with MRSA
Exclusion Criteria:
Currently on treatment with antibiotics
Pregnant or breastfeeding women
Active infection
Hepatic cirrhosis or abnormal INR due to liver disease
Decolonization in the previous two (2) months
MRSA bacteria resistant to one or more of the study medications
AST and ALT levels more than five times the upper limit of normal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duncan Webster, MA, MD
Organizational Affiliation
Horizon Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L4L2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
17173213
Citation
Simor AE, Phillips E, McGeer A, Konvalinka A, Loeb M, Devlin HR, Kiss A. Randomized controlled trial of chlorhexidine gluconate for washing, intranasal mupirocin, and rifampin and doxycycline versus no treatment for the eradication of methicillin-resistant Staphylococcus aureus colonization. Clin Infect Dis. 2007 Jan 15;44(2):178-85. doi: 10.1086/510392. Epub 2006 Dec 14.
Results Reference
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Randomized Controlled Trial of Standard Versus Systemic Decolonization Therapy for the Eradication of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
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