Randomized Controlled Trial of Standard Versus Systemic Decolonization Therapy for the Eradication of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
- Conditions
- Methicillin-resistant Staphylococcus Aureus
- Interventions
- Registration Number
- NCT01438515
- Lead Sponsor
- Horizon Health Network
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Any patient colonized with MRSA
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard decolonization 4% chlorhexidine gluconate 7-day course of 2% mupirocin ointment to the anterior nares twice daily and 4% chlorhexidine gluconate washes once per day. Systemic decolonization 4% chlorhexidine gluconate 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) Systemic decolonization 2% mupirocin ointment 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) Standard decolonization 2% mupirocin ointment 7-day course of 2% mupirocin ointment to the anterior nares twice daily and 4% chlorhexidine gluconate washes once per day. Systemic decolonization Doxycycline 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) Systemic decolonization Rifampin 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)
- Primary Outcome Measures
Name Time Method Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months 12 months To compare standard versus systemic decolonization for their ability to sustain MRSA decolonization up to one year post-decolonization.
- Secondary Outcome Measures
Name Time Method Changes in susceptibility patterns of MRSA isolates. 12 months 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.
Trial Locations
- Locations (1)
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada