Human Microbiome
Conditions
Keywords
intranasal mupirocin, topical chlorhexidine
Brief 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.
Interventions
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.
DRUGTopical Chlorhexidine, 4%
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
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
30 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.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Mupirocin calcium ointment, 2%: 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.
Topical Chlorhexidine, 4%: 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. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Intranasal Mupirocin and Topical Chlorhexidine |
|---|---|
| Age, Continuous | 50.5 years STANDARD_DEVIATION 17.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 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 | 10 Participants |
| Region of Enrollment United States | 28 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
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
Population: Out of the 28 participants assigned to this group, 2 were lost to follow-up and 1 had an insufficient amount of sample collected and could not be included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Mupirocin and Topical Chlorhexidine | Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization | -781 fg/uL | Standard Deviation 3681 |
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
Population: Out of the 28 participants assigned to this group, 2 were lost to follow-up and 1 had an insufficient amount of sample collected and could not be included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Mupirocin and Topical Chlorhexidine | Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization | -321 fg/uL | Standard Deviation 7053 |