Randomized Controlled Trial of Standard Versus Systemic Decolonization Therapy for the Eradication of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Methicillin-resistant Staphylococcus Aureus

Intervention / Treatment
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* Drug: Rifampin
* Drug: Doxycycline
* Other: 2% mupirocin ointment
* Other: 4% chlorhexidine gluconate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systemic decolonization<br>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) | Drug: Rifampin<br>* 600mg po once daily x 7 days<br>Drug: Doxycycline<br>* 100mg po twice daily x 7 days<br>Other: 2% mupirocin ointment<br>*   1cm applied to the anterior nares twice daily for 7 days<br>Other: 4% chlorhexidine gluconate<br>* Daily full body wash (including hair) for 7 days<br>|
| Active Comparator: Standard decolonization<br>7-day course of 2% mupirocin ointment to the anterior nares twice daily and 4% chlorhexidine gluconate washes once per day. | Other: 2% mupirocin ointment<br>*   1cm applied to the anterior nares twice daily for 7 days<br>Other: 4% chlorhexidine gluconate<br>* Daily full body wash (including hair) for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRSA, doxycycline, rifampin, mupirocin, chlorhexidine gluconate, decolonization, methicillin-resistant staphylococcus aureus