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

VA Office of Research and Development

Status and phase: Completed; Phase 4

Conditions: Human Microbiome

Treatments: Drug: Topical Chlorhexidine, 4%; Drug: Mupirocin calcium ointment, 2%

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04222699

INFB-018-01CX

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Intranasal Mupirocin and Topical Chlorhexidine

Experimental group

Description:

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.

Treatment:

Drug: Topical Chlorhexidine, 4%

Drug: Mupirocin calcium ointment, 2%