Phase 4
N=28
Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization
Human Microbiome
Bottom Line
View on ClinicalTrials.gov: NCT04222699 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization — -781 fg/uL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mupirocin calcium ointment, 2% (Drug); Topical Chlorhexidine, 4% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization |
-781 | — |
| PRIMARY Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization |
-321 | — |
| PRIMARY Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization |
— | — |
| PRIMARY Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization |
— | — |
Summary
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.
Eligibility Criteria
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 100 F at enrollment visit
- BMI 35 at enrollment visit
Data sourced from ClinicalTrials.gov (NCT04222699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.