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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Mupirocin and Topical Chlorhexidine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 12 months |
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary-Claire Roghmann, MD | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | fg/uL | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary-Claire Roghmann | VA Maryland Healthcare System | 410 706 0062 | mroghmann@som.umaryland.edu |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| 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. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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. | 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. | Posted | Mean | Standard Deviation | fg/uL | 8 weeks |
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| 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. | Subclavian skin samples deteriorated prior to sample analysis and cannot be used. | Posted | 12 months |
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| 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. | Femoral skin samples deteriorated prior to sample analysis and cannot be used. | Posted | 12 months |
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| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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