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

NCT04222699 | Completed Phase 4 Results FDA Drug

• 1 other identifier: INFB-018-01CX
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

intranasal mupirocin; topical chlorhexidine

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Intranasal Mupirocin and Topical Chlorhexidine

EXPERIMENTAL

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%; Drug: Topical Chlorhexidine, 4%

Interventions

Mupirocin calcium ointment, 2% 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.

Also known as: BACTROBAN NASAL ointment

Intranasal Mupirocin and Topical Chlorhexidine

Topical Chlorhexidine, 4% 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.

Intranasal Mupirocin and Topical Chlorhexidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Dr. Mary-Claire Roghmann
• Organization: VA Maryland Healthcare System

mroghmann@som.umaryland.edu

410 706 0062

Study Officials

• Mary-Claire Roghmann, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: January 10, 2020
• Study Start: September 18, 2012
• Primary Completion: November 18, 2014
• Study Completion: November 18, 2014
• Last Updated: April 14, 2020
• Results First Posted: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)