MedPath

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

Phase 4
Completed
Conditions
Human Microbiome
Interventions
Drug: Topical Chlorhexidine, 4%
Registration Number
NCT04222699
Lead Sponsor
VA Office of Research and Development
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
58
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Intranasal Mupirocin and Topical ChlorhexidineMupirocin calcium ointment, 2%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.
Intranasal Mupirocin and Topical ChlorhexidineTopical Chlorhexidine, 4%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.
Primary Outcome Measures
NameTimeMethod
Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization8 weeks

Change in the abundance of Staphylococcus aureus in the nose from immediately before mupirocin administration to 8 weeks after mupirocin administration.

Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization8 weeks

Change in the abundance of Staphylococcus aureus in the throat from immediately before mupirocin administration to 8 weeks after mupirocin administration.

Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization12 months

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.

Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization12 months

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

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Baltimore, Maryland, United States

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