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

NCT ID: NCT04218799

Last Updated: 2023-06-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-12

Study Completion Date

2015-09-22

Brief Summary

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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

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Conditions

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Human Microbiome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intranasal Mupirocin and Topical Chlorhexidine

Group Type EXPERIMENTAL

Intranasal Mupirocin and Topical Chlorhexidine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Mary-Claire Roghmann

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary-Claire Roghmann, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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Loch Raven VA Community Living Center

Baltimore, Maryland, United States

Site Status

Perry Point VA Community Living Center

Perry Point, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HP-00058923

Identifier Type: -

Identifier Source: org_study_id

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