Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization

Study Overview
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Brief Summary
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The investigators propose to study the microbiome of the nose, throat and three skin sites in a population without current exposure to the healthcare environment: 80 community dwelling adults. We will characterize the microbial communities in these body sites (nose, throat, perirectal and three skin sites) over time using culture-independent techniques. The investigators will then decolonize the subjects. Subjects will receive intranasal mupirocin and topical chlorhexidine. The investigators will then compare the microbial communities at baseline and after decolonization within individuals. Our overall hypothesis is that the microbial composition of these sites and the response to decolonization is influenced by the healthcare environment and that decolonization leads to re-colonization with an increasing proportion of Gram-negative bacilli.

Official Title
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Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization

Conditions
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Human Microbiome

Intervention / Treatment
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* Drug: Mupirocin calcium ointment, 2%
* Drug: Topical Chlorhexidine, 4%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veteran living in the greater Baltimore, MD area Adults >= 18 years of age Living independently Willing and able to provide anterior nares, skin, throat, and perirectal specimens over an 18 week time period. Willing and able to administer intranasal mupirocin and topical chlorhexidine over a five day period Capable of understanding and complying with the entire study protocol. Provided signed and dated informed consent Exclusion Criteria: Use of anticancer chemotherapy or radiation therapy (cytotoxic) within the past 6 months History of HIV infection with most recent CD4 of <200 Immunosuppression medications within the past 3 months Use of systemic antibacterial or antifungal agents in the past 3 months Use of nasal steroids currently or in the past 3 months Use of nasal antimicrobial ointment in the past 3 months Any current indwelling percutaneous medical device or urinary catheter Acute care hospitalization in the past 3 months Planned surgery or hospitalization during the study period History of an allergic reaction to chlorhexidine or mupirocin Oral temperature of >100 F at enrollment visit BMI <18 or >35 at enrollment visit

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Mupirocin and Topical Chlorhexidine<br>Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study. | Drug: Mupirocin calcium ointment, 2%<br>* Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth.<br>* Other names: BACTROBAN NASAL ointment;Drug: Topical Chlorhexidine, 4%<br>* Chlorhexidine is an antiseptic that fights bacteria. Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization | Change in the abundance of Staphylococcus aureus in the nose from immediately before mupirocin administration to 8 weeks after mupirocin administration. | 8 weeks | 
| Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization | Change in the abundance of Staphylococcus aureus in the throat from immediately before mupirocin administration to 8 weeks after mupirocin administration. | 8 weeks | 
| Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization | Quantitative PCR using 16S rRNA is used to quantify the total bacterial load of Gram negative bacteria on the subclavian skin before and after decolonization. | 12 months | 
| Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization | Quantitative PCR using 16S rRNA is used to quantify the total bacterial load of Gram negative bacteria on the femoral skin before and after decolonization. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intranasal mupirocin, topical chlorhexidine