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

Human Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04222699
• Other study ID #: INFB-018-01CX
• Status: Completed
• Phase: Phase 4
• Start date: September 18, 2012
• Est. completion date: November 18, 2014

Study information

• Verified date: April 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 18, 2014
• Est. primary completion date: November 18, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human Microbiome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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