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Completed

NCT Number: NCT04218799

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.

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Key information

Conditions

Human Microbiome

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Loch Raven VA Community Living Center, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal Mupirocin and Topical Chlorhexidine

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.

Primary outcomes

  1. Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization

    Time frame: 8 weeks

    Change in the abundance of Staphylococcus aureus in the nose from immediately before mupirocin administration to 8 weeks after mupirocin administration.

  2. Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization

    Time frame: 8 weeks

    Change in the abundance of Staphylococcus aureus in the throat from immediately before mupirocin administration to 8 weeks after mupirocin administration.

  3. Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization

    Time frame: 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.

  4. Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • VA Office of Research and Development

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 6, 2020
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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