Clinical trial NCT04222699: Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization
Official title: Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Human Microbiome
Keywords: intranasal mupirocin
topical chlorhexidine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-01-10
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization
timeFrame: 8 weeks
measure: Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization
timeFrame: 8 weeks
measure: Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization
timeFrame: 12 months
measure: Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Mary-Claire Roghmann, MD
role: PRINCIPAL_INVESTIGATOR
References: