Back to resultsHuman Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans
Primary Purpose
Human Microbiome
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intranasal Mupirocin and Topical Chlorhexidine
Sponsored by
About this trial
This is an interventional health services research trial for Human Microbiome focused on measuring intranasal mupirocin, topical chlorhexidine
Eligibility Criteria
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
Sites / Locations
- Loch Raven VA Community Living Center
- Perry Point VA Community Living Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intranasal Mupirocin and Topical Chlorhexidine
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04218799
First Posted
December 20, 2019
Last Updated
June 5, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04218799
Brief Title
Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans
Official Title
Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2014 (Actual)
Primary Completion Date
September 22, 2015 (Actual)
Study Completion Date
September 22, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Microbiome
Keywords
intranasal mupirocin, topical chlorhexidine
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intranasal Mupirocin and Topical Chlorhexidine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Intranasal Mupirocin and Topical Chlorhexidine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization
Description
Change in the abundance of Staphylococcus aureus in the nose from immediately before mupirocin administration to 8 weeks after mupirocin administration.
Time Frame
8 weeks
Title
Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization
Description
Change in the abundance of Staphylococcus aureus in the throat from immediately before mupirocin administration to 8 weeks after mupirocin administration.
Time Frame
8 weeks
Title
Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization
Description
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.
Time Frame
12 months
Title
Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary-Claire Roghmann, MD, MS
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loch Raven VA Community Living Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Perry Point VA Community Living Center
City
Perry Point
State/Province
Maryland
ZIP/Postal Code
21902
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans
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