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OpenTrials
Completed

NCT Number: NCT04222699

Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization

The investigators propose to study the microbiome of the nose, throat and three skin sites in a population without current exposure to the healthcare environment: 80 community dwelling adults. We will characterize the microbial communities in these body sites (nose, throat, perirectal and three skin sites) over time using culture-independent techniques. The investigators will then "decolonize" the subjects. Subjects will receive intranasal mupirocin and topical chlorhexidine. The investigators will then compare the microbial communities at baseline and after decolonization within individuals. Our overall hypothesis is that the microbial composition of these sites and the response to decolonization is influenced by the healthcare environment and that decolonization leads to re-colonization with an increasing proportion of Gram-negative bacilli.

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Key information

Conditions

Human Microbiome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Veteran living in the greater Baltimore, MD area
  • Adults >= 18 years of age
  • Living independently
  • Willing and able to provide anterior nares, skin, throat, and perirectal specimens over an 18 week time period.
  • Willing and able to administer intranasal mupirocin and topical chlorhexidine over a five day period
  • Capable of understanding and complying with the entire study protocol.
  • Provided signed and dated informed consent

Exclusion criteria

  • Use of anticancer chemotherapy or radiation therapy (cytotoxic) within the past 6 months
  • History of HIV infection with most recent CD4 of <200
  • Immunosuppression medications within the past 3 months
  • Use of systemic antibacterial or antifungal agents in the past 3 months
  • Use of nasal steroids currently or in the past 3 months
  • Use of nasal antimicrobial ointment in the past 3 months
  • Any current indwelling percutaneous medical device or urinary catheter
  • Acute care hospitalization in the past 3 months
  • Planned surgery or hospitalization during the study period
  • History of an allergic reaction to chlorhexidine or mupirocin
  • Oral temperature of >100 F at enrollment visit
  • BMI <18 or >35 at enrollment visit

Treatment and study plan

mupirocin calcium ointment, 2%

Drug

Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth.

Other names: BACTROBAN NASAL ointment

Topical Chlorhexidine, 4%

Drug

Chlorhexidine is an antiseptic that fights bacteria.

Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury.

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

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 10, 2020
Registry last updated
Apr 14, 2020

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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