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

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.

Study Overview

• Status: Completed
• Conditions: Human Microbiome
• Intervention / Treatment: Drug: Intranasal Mupirocin and Topical Chlorhexidine

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Loch Raven VA Community Living Center
    • Perry Point, Maryland, United States, 21902
      • Perry Point VA Community Living Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intranasal Mupirocin and Topical Chlorhexidine	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: VA Office of Research and Development
• Investigators: Principal Investigator: Mary-Claire Roghmann, MD, MS, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2014
• Primary Completion (Actual): September 22, 2015
• Study Completion (Actual): September 22, 2015

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: topical chlorhexidine; intranasal mupirocin
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Iatrogenic Disease; Cross Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Disinfectants; Mupirocin; Chlorhexidine
• Other Study ID Numbers: HP-00058923

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No