Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans

Human Microbiome Clinical Trial

Official title:

Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04218799
• Other study ID #: HP-00058923
• Status: Completed
• Phase: Phase 4
• Start date: August 12, 2014
• Est. completion date: September 22, 2015

Study information

• Verified date: June 2023
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the research is to find out the effect of commonly used topical antibiotics on the bacteria that live in the nose, throat and on the skin of older adults. In addition, the investigators want to determine if these topical antibiotics affect how bacteria are spread in Community Living Centers of the VA Maryland Health Care System.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 22, 2015
• Est. primary completion date: September 22, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Age 50 years or older.
• Living in a participating nursing home for at least 80% of the past 3 months-
• Willing to provide anterior nares, posterior pharynx, skin and throat specimens over the study period.
• Willing to use intranasal mupirocin and topical chlorhexidine over a five day period.
• Provide signed and dated informed consent from subject or LAR.

Exclusion Criteria:

• Recent history of MRSA colonization
• Use of mupirocin nasal ointment in past 3 months
• Use of topical chlorhexidine in past 3 months
• History of an allergic reaction to chlorhexidine or mupirocin

Related Conditions & MeSH terms

• Cross Infection
• Human Microbiome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Loch Raven VA Community Living Center	Baltimore	Maryland
United States	Perry Point VA Community Living Center	Perry Point	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	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