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

Phase 4

Completed

• Conditions: Human Microbiome
• Interventions: Drug: Intranasal Mupirocin and Topical Chlorhexidine

• Registration Number: NCT04218799
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-12
• Primary Completion: 2015-09-22
• Study Completion: 2015-09-22
• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-06
• Results First Submitted: 2020-03-31
• Results First Submitted QC: 2020-04-10
• Results First Posted: 2020-04-24
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intranasal Mupirocin and Topical Chlorhexidine	Intranasal Mupirocin and Topical Chlorhexidine	-

Primary Outcome Measures

Name	Time	Method
Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization	8 weeks	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 Gram Negative Bacteria on the Subclavian Skin After Decolonization	12 months	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 Staphylococcus Aureus in the Throat After Decolonization	8 weeks	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 Femoral Skin After Decolonization	12 months	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.

Trial Locations

Locations (2)

Loch Raven VA Community Living Center; 🇺🇸 Baltimore, Maryland, United States

Perry Point VA Community Living Center; 🇺🇸 Perry Point, Maryland, United States