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The purpose of this research study is to compare the effectiveness of commonly used decolonization treatments (application of mupirocin antibiotic ointment to the nose and bleach baths) when performed by individuals with a history of skin and soft tissue infection (SSTI) in the prior year (individualized approach) in comparison to decolonization of all household members (household approach) in an attempt to prevent Staphylococcus aureus skin infections. The investigators hypothesize an individualized decolonization approach will be equally as effective as a household approach to prevent SSTI.
Methicillin-resistant Staphylococcus aureus (MRSA) was once uniformly associated with hospital-acquired infections; however, MRSA strains have emerged that thrive outside the hospital environment, causing significant morbidity and mortality among immunocompetent individuals, leading to their designation as community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA).
There is no available vaccine against S. aureus. Thus, other preventive measures, including topical antimicrobial therapies, have been used in an attempt to prevent staphylococcal infections. These therapies include mupirocin (a topical antibiotic with activity against MRSA) and dilute bleach water baths. The effectiveness of these measures directed at patients colonized with traditional MSSA and HA-MRSA strains in an attempt to prevent nosocomial infections varies across studies, and maintenance of eradication diminishes over time. With the emergence of the CA-MRSA epidemic, these measures have been extrapolated to patients in community settings. We aim to find a practical approach to decolonization which patients can feasibly perform at home to reduce the incidence of skin and soft tissue infections(SSTI).
Specific Aim: Compare the effectiveness of decolonization of individuals with a history of SSTI in the prior year (individualized approach) to decolonization of all household members (household approach) in reducing the incidence of recurrent SSTI. Primary hypothesis: An individualized decolonization approach will be equally as effective as decolonization of all household members to prevent SSTI. Secondary hypothesis: Application of mupirocin to the anterior nares twice daily for 5 days will not result in a higher prevalence of colonization with mupirocin-resistant strains at subsequent longitudinal samplings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized Approach | Active Comparator | The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. |
|
| Household Approach | Active Comparator | All members of the household will perform the decolonization regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% mupirocin ointment | Drug | Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Incidence of SSTI at 3 Months After Decolonization | Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol | 3 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Incidence of SSTI at 1 Month After Decolonization | Cumulative Number of Participants with SSTI at any time during the 1 Month following Decolonization protocol | 1 month after enrollment |
| Number of Participants With Incidence of SSTI at 6 Months After Decolonization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie A Fritz, MD, MSCI | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32521007 | Derived | Hogan PG, Parrish KL, Mork RL, Boyle MG, Muenks CE, Thompson RM, Morelli JJ, Sullivan ML, Hunstad DA, Bubeck Wardenburg J, Rzhetsky A, Gehlert SJ, Burnham CD, Fritz SA. HOME2 Study: Household Versus Personalized Decolonization in Households of Children With Methicillin-Resistant Staphylococcus aureus Skin and Soft Tissue Infection-A Randomized Clinical Trial. Clin Infect Dis. 2021 Dec 6;73(11):e4568-e4577. doi: 10.1093/cid/ciaa752. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Individualized Approach | The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips:
|
| FG001 | Household Approach | All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Individualized Approach | The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Incidence of SSTI at 3 Months After Decolonization | Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol | 447 of 474 participants were analyzed. The remaining 27 participants were lost to follow up for this time frame. | Posted | Count of Participants | Participants | 3 months after enrollment |
|
1 year
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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 | Individualized Approach | The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips:
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching (from mupirocin) | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Fritz, MD, MSCI | Washington University School of Medicine | 3144544115 | fritz.s@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2013 | Jul 26, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013207 | Staphylococcal Skin Infections |
| D000038 | Abscess |
| D005667 | Furunculosis |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D016712 | Mupirocin |
| D007201 | Indicator Dilution Techniques |
| D012973 | Sodium Hypochlorite |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
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|
| Bleach Bath (dilute) | Other | Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. |
|
|
| Hygiene Protocol | Behavioral | Follow key hygiene tips:
|
|
Cumulative Number of Participants with SSTI at any time during the 6 Months following Decolonization protocol |
| 6 months after enrollment |
| Number of Participants With Incidence of SSTI at 9 Months After Decolonization | Cumulative Number of Participants with SSTI at any time during the 9 Months following Decolonization protocol | 9 months after enrollment |
| Number of Participants With Incidence of SSTI at 12 Months After Decolonization | Cumulative Number of Participants with SSTI at any time during the 12 Months following Decolonization protocol | 12 months after enrollment |
| Number of Participants Colonized With MRSA at 1 Month After Decolonization | Number of Participants Colonized with MRSA at the 1 Month longitudinal study visit | 1 month after enrollment |
| Number of Participants Colonized With MRSA at 3 Months After Decolonization | Number of Participants Colonized with MRSA at the 3 Month longitudinal study visit | 3 months after enrollment |
| Number of Participants Colonized With MRSA at 6 Months After Decolonization | Number of Participants Colonized with MRSA at the 6 Month longitudinal study visit | 6 months after enrollment |
| Number of Participants Colonized With MRSA at 9 Months After Decolonization | Number of Participants Colonized with MRSA at the 9 Month longitudinal study visit | 9 months after enrollment |
| Number of Participants Colonized With MRSA at 12 Months After Decolonization | Number of Participants Colonized with MRSA at the 12 Month longitudinal study visit | 12 months after enrollment |
| Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period | Number of participants who report development of Nasal burning, itching, stinging, or runny nose or Skin itching, dry skin, or rash during the decolonization period. | 1 week after enrollment |
| Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance | Number of all recovered S. aureus isolates resistant to mupirocin at the study visit before decolonization protocol and the study visit immediately after decolonization protocol | 1 month |
| Number of Participants Incurring Economic Burden of Performing Protocol | Number of participants incurring additional costs during their compliance with prescribed hygiene measures prescribed with the decolonization regimen: e.g., cost of containers of lotion or bars of soap discarded, cost of new pump or pour lotion or soap purchased, cost of new personal hygiene items or linens, cost of additional loads of laundry | 1 month after enrollment |
| Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period. | Number of participants reporting the development of a MRSA infection over the year of longitudinal follow-up that has been culture- and physician-confirmed through verification by medical record and culture report. | 1 Year |
| Number of Participants Adhering to Decolonization Measures | Number of participants Adhering to decolonization measures. Defined as reported completion of at least 4 of the 5 assigned days (8 or more mupirocin applications and 4 or more bleach baths) | 1 week |
| BG001 | Household Approach | All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips:
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height (inches) | Mean | Standard Deviation | inches |
|
| Weight (pounds) | Mean | Standard Deviation | pounds |
|
| OG001 | Household Approach | All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips:
|
|
|
|
| Secondary | Number of Participants With Incidence of SSTI at 1 Month After Decolonization | Cumulative Number of Participants with SSTI at any time during the 1 Month following Decolonization protocol | 449 of 474 participants were analyzed. The remaining 25 participants were lost to follow up for this time frame. | Posted | Count of Participants | Participants | 1 month after enrollment |
|
|
|
|
| Secondary | Number of Participants With Incidence of SSTI at 6 Months After Decolonization | Cumulative Number of Participants with SSTI at any time during the 6 Months following Decolonization protocol | 434 of 474 participants were analyzed. The remaining 40 participants were lost to follow up for this time frame. | Posted | Count of Participants | Participants | 6 months after enrollment |
|
|
|
|
| Secondary | Number of Participants With Incidence of SSTI at 9 Months After Decolonization | Cumulative Number of Participants with SSTI at any time during the 9 Months following Decolonization protocol | 433 of 474 participants were analyzed. The remaining 41 participants were lost to follow up for this time frame. | Posted | Count of Participants | Participants | 9 months after enrollment |
|
|
|
|
| Secondary | Number of Participants With Incidence of SSTI at 12 Months After Decolonization | Cumulative Number of Participants with SSTI at any time during the 12 Months following Decolonization protocol | 417 of 474 participants were analyzed. The remaining 57 participants were lost to follow up for this time frame. | Posted | Count of Participants | Participants | 12 months after enrollment |
|
|
|
|
| Secondary | Number of Participants Colonized With MRSA at 1 Month After Decolonization | Number of Participants Colonized with MRSA at the 1 Month longitudinal study visit | 438 of 474 participants were analyzed. The remaining 36 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit. | Posted | Count of Participants | Participants | 1 month after enrollment |
|
|
|
|
| Secondary | Number of Participants Colonized With MRSA at 3 Months After Decolonization | Number of Participants Colonized with MRSA at the 3 Month longitudinal study visit | 433 of 474 participants were analyzed. The remaining 41 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit. | Posted | Count of Participants | Participants | 3 months after enrollment |
|
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|
|
| Secondary | Number of Participants Colonized With MRSA at 6 Months After Decolonization | Number of Participants Colonized with MRSA at the 6 Month longitudinal study visit | 431 of 474 participants were analyzed. The remaining 43 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit. | Posted | Count of Participants | Participants | 6 months after enrollment |
|
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|
|
| Secondary | Number of Participants Colonized With MRSA at 9 Months After Decolonization | Number of Participants Colonized with MRSA at the 9 Month longitudinal study visit | 422 of 474 participants were analyzed. The remaining 52 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit. | Posted | Count of Participants | Participants | 9 months after enrollment |
|
|
|
|
| Secondary | Number of Participants Colonized With MRSA at 12 Months After Decolonization | Number of Participants Colonized with MRSA at the 12 Month longitudinal study visit | 407 of 474 participants were analyzed. The remaining 67 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit. | Posted | Count of Participants | Participants | 12 months after enrollment |
|
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|
|
| Secondary | Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period | Number of participants who report development of Nasal burning, itching, stinging, or runny nose or Skin itching, dry skin, or rash during the decolonization period. | 309 participants were assigned decolonization measures as part of the protocol. Of these 11 participants were lost to follow-up and never returned their adherence documents. 4 participants did not complete any part of the assigned decolonization measures. The remaining 294 participants are analyzed. | Posted | Count of Participants | Participants | 1 week after enrollment |
|
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| Secondary | Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance | Number of all recovered S. aureus isolates resistant to mupirocin at the study visit before decolonization protocol and the study visit immediately after decolonization protocol | All participants swabbed before decolonization. 438 participants swabbed at 1 mo. follow-up (after decolonization) - remaining 36 lost to follow-up or unavailable for swabs at home visit. This SECONDARY outcome is independent of study group, as the impact of the study on mupirocin resistance in overall study population is the outcome measure. | Posted | Count of Units | Isolates Analyzed/Recovered | 1 month | Isolates Analyzed/Recovered | Isolates Analyzed/Recovered |
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| Secondary | Number of Participants Incurring Economic Burden of Performing Protocol | Number of participants incurring additional costs during their compliance with prescribed hygiene measures prescribed with the decolonization regimen: e.g., cost of containers of lotion or bars of soap discarded, cost of new pump or pour lotion or soap purchased, cost of new personal hygiene items or linens, cost of additional loads of laundry | 435 of 474 participants returned their cost of protocol documentation. This SECONDARY outcome is independent of study group, as the economic impact of the study in the overall study population is the outcome measure. | Posted | Count of Participants | Participants | 1 month after enrollment |
|
|
|
| Secondary | Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period. | Number of participants reporting the development of a MRSA infection over the year of longitudinal follow-up that has been culture- and physician-confirmed through verification by medical record and culture report. | 416 of 474 participants were analyzed. The remaining 58 participants were lost to follow up for this time frame and outcome. | Posted | Count of Participants | Participants | 1 Year |
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| Secondary | Number of Participants Adhering to Decolonization Measures | Number of participants Adhering to decolonization measures. Defined as reported completion of at least 4 of the 5 assigned days (8 or more mupirocin applications and 4 or more bleach baths) | 309 participants were assigned decolonization measures as part of the protocol. Of these 11 participants were lost to follow-up and never returned their adherence documents. The remaining 298 participants are analyzed. | Posted | Count of Participants | Participants | 1 week |
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|
| 0 |
| 248 |
| 0 |
| 248 |
| 41 |
| 248 |
| EG001 | Household Approach | All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips:
| 0 | 226 | 0 | 226 | 102 | 226 |
| Runny nose (from mupirocin) | General disorders | Systematic Assessment |
|
| Itching (from bleach baths) | General disorders | Systematic Assessment |
|
| Dry skin (from bleach baths) | General disorders | Systematic Assessment |
|
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| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013492 | Suppuration |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005393 | Fish Diseases |
| D000820 | Animal Diseases |
| D011714 |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D008919 | Investigative Techniques |
| D006997 | Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017670 | Sodium Compounds |