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

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.

Study Overview

• Status: Completed
• Conditions: Human Microbiome
• Intervention / Treatment: Drug: Mupirocin calcium ointment, 2%; Drug: Topical Chlorhexidine, 4%

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Drug: 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.; Other Names: BACTROBAN NASAL ointment; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2012
• Primary Completion (ACTUAL): November 18, 2014
• Study Completion (ACTUAL): November 18, 2014

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (ACTUAL): January 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: topical chlorhexidine; intranasal mupirocin
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Calcium-Regulating Hormones and Agents; Disinfectants; Calcium; Mupirocin; Chlorhexidine
• Other Study ID Numbers: INFB-018-01CX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No