Human Microbiome
Conditions
Keywords
intranasal mupirocin, topical chlorhexidine
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.
Interventions
DRUGIntranasal 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.
Sponsors
VA Office of Research and Development
University of Maryland, Baltimore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization | 8 weeks | Change in the abundance of Staphylococcus aureus in the nose from immediately before mupirocin administration to 8 weeks after mupirocin administration. |
| Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization | 8 weeks | Change in the abundance of Staphylococcus aureus in the throat from immediately before mupirocin administration to 8 weeks after mupirocin administration. |
| Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization | 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. |
| Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization | 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. |
Countries
United States
Participant flow
Pre-assignment details
11 participants were S. aureus negative in the nose at enrollment and were withdrawn from the study as the use of mupirocin was not clinically indicated. 1 participant was discharged from the nursing home prior to receiving mupirocin.
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Mupirocin and Topical Chlorhexidine 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. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Intranasal Mupirocin and Topical Chlorhexidine |
|---|---|
| Age, Continuous | 71.0 years STANDARD_DEVIATION 14.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
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.
Time frame: 12 months
Population: Femoral skin samples deteriorated prior to sample analysis and cannot be used.
Primary
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.
Time frame: 12 months
Population: Subclavian skin samples deteriorated prior to sample analysis and cannot be used.
Primary
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Mupirocin and Topical Chlorhexidine | Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization | -4174 fg/uL | Standard Deviation 11003 |
Primary
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Mupirocin and Topical Chlorhexidine | Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization | -3395 fg/uL | Standard Deviation 8954 |