Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus (MRSA) in the Outpatient Setting

Study Overview
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Brief Summary
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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.

Official Title
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Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus in the Outpatient Setting: a Randomized Controlled Study

Conditions
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Methicillin-resistant Staphylococcus Aureus

Intervention / Treatment
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* Drug: pharmacological decolonization treatment
* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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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.

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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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: decolonization treatment<br>topical antiseptic, intranasal antimicrobial, and oral antimicrobial that have activity against MRSA in addition to education regarding personal hygiene and environmental cleaning | Drug: pharmacological decolonization treatment<br>* 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<br>|
| Other: education<br>No decolonization treatment in addition to education regarding personal hygiene and environmental cleaning | Behavioral: Education<br>* No pharmacological decolonization treatment but given education regarding personal hygiene and environmental cleaning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication of MRSA carriage |  | 90 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of MRSA infection |  | Within 6 months of randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methicillin-resistant Staphylococcus aureus, decolonization, random allocation, outpatient