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

NCT ID: NCT04222699

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-18
• Study Completion Date: 2014-11-18

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.

Conditions

Human Microbiome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intranasal Mupirocin and Topical Chlorhexidine

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.

Group Type: EXPERIMENTAL

Mupirocin calcium ointment, 2%

Intervention Type: DRUG

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.

Topical Chlorhexidine, 4%

Intervention Type: DRUG

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.

Interventions

Mupirocin calcium ointment, 2%

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.

Intervention Type: DRUG

Topical Chlorhexidine, 4%

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.

Intervention Type: DRUG

Other Intervention Names

BACTROBAN NASAL ointment

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary-Claire Roghmann, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

INFB-018-01CX

Identifier Type: -

Identifier Source: org_study_id