NCT04218799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2015

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 24, 2020

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

December 20, 2019

Results QC Date

March 31, 2020

Last Update Submit

June 5, 2023

Conditions

Human Microbiome

Keywords

intranasal mupirocintopical chlorhexidine

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Intranasal Mupirocin and Topical Chlorhexidine

EXPERIMENTAL
Drug: Intranasal Mupirocin and Topical Chlorhexidine

Interventions

Intranasal Mupirocin and Topical ChlorhexidineDRUG

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.

Intranasal Mupirocin and Topical Chlorhexidine

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Loch Raven VA Community Living Center

Baltimore, Maryland, 21218, United States

Location

Perry Point VA Community Living Center

Perry Point, Maryland, 21902, United States

Location

MeSH Terms

Interventions

Chlorhexidine

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Dr. Mary-Claire Roghmann
Organization
University of Maryland School of Medicine
mroghmann@som.umaryland.edu
410 706 0062

Study Officials

  • Mary-Claire Roghmann, MD, MS

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2019

First Posted

January 6, 2020

Study Start

August 12, 2014

Primary Completion

September 22, 2015

Study Completion

September 22, 2015

Last Updated

June 6, 2023

Results First Posted

April 24, 2020

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)