Abscess, Furunculosis, MRSA Infection, Staphylococcal Skin Infection, Staphylococcus Aureus
Conditions
Keywords
Abscesses, Furunculosis, Staphylococcus aureus colonization, Staphylococcal Skin Infection, MRSA
Brief summary
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.
Detailed description
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.
Interventions
Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.
OTHERBleach 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.
BEHAVIORALHygiene Protocol
Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Individuals who are enrolled in a 12-month observational study entitled The Community-Associated Methicillin-Resistant Staphylococcus aureus Among Household Members and the Home Environment Study.
Exclusion criteria
* Households in which all members experienced SSTI during the 12-month observational study * Individuals with known allergies to mupirocin or bleach (sodium hypochlorite)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Incidence of SSTI at 3 Months After Decolonization | 3 months after enrollment | Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Incidence of SSTI at 6 Months After Decolonization | 6 months after enrollment | Cumulative Number of Participants with SSTI at any time during the 6 Months following Decolonization protocol |
| Number of Participants With Incidence of SSTI at 9 Months After Decolonization | 9 months after enrollment | Cumulative Number of Participants with SSTI at any time during the 9 Months following Decolonization protocol |
| Number of Participants With Incidence of SSTI at 12 Months After Decolonization | 12 months after enrollment | Cumulative Number of Participants with SSTI at any time during the 12 Months following Decolonization protocol |
| Number of Participants Colonized With MRSA at 1 Month After Decolonization | 1 month after enrollment | Number of Participants Colonized with MRSA at the 1 Month longitudinal study visit |
| Number of Participants Colonized With MRSA at 3 Months After Decolonization | 3 months after enrollment | Number of Participants Colonized with MRSA at the 3 Month longitudinal study visit |
| Number of Participants Colonized With MRSA at 6 Months After Decolonization | 6 months after enrollment | Number of Participants Colonized with MRSA at the 6 Month longitudinal study visit |
| Number of Participants With Incidence of SSTI at 1 Month After Decolonization | 1 month after enrollment | Cumulative Number of Participants with SSTI at any time during the 1 Month following Decolonization protocol |
| Number of Participants Colonized With MRSA at 12 Months After Decolonization | 12 months after enrollment | Number of Participants Colonized with MRSA at the 12 Month longitudinal study visit |
| Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period | 1 week after enrollment | 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. |
| Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance | 1 month | 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 |
| Number of Participants Incurring Economic Burden of Performing Protocol | 1 month after enrollment | 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 |
| Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period. | 1 Year | 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. |
| Number of Participants Adhering to Decolonization Measures | 1 week | 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) |
| Number of Participants Colonized With MRSA at 9 Months After Decolonization | 9 months after enrollment | Number of Participants Colonized with MRSA at the 9 Month longitudinal study visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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:
* Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
* Use liquid(pour or pump) soaps instead of bar soaps.
* Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
* Do not share personal care items such as razors, brushes, or deodorant.
* Wash all sheets and towels in hot water. Wash sheets every week.
* Use towels and wash cloths only once before washing and do not share. | 248 |
| 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:
* Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
* Use liquid(pour or pump) soaps instead of bar soaps.
* Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
* Do not share personal care items such as razors, brushes, or deodorant.
* Wash all sheets and towels in hot water. Wash sheets every week.
* Use towels and wash cloths only once before washing and do not share. | 226 |
| Total | 474 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 30 | 27 |
Baseline characteristics
| Characteristic | Household Approach | Total | Individualized Approach |
|---|---|---|---|
| Age, Categorical <=18 years | 128 Participants | 273 Participants | 145 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 97 Participants | 198 Participants | 101 Participants |
| Age, Continuous | 18.69 years STANDARD_DEVIATION 15.94 | 18.67 years STANDARD_DEVIATION 16.3 | 18.65 years STANDARD_DEVIATION 16.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 29 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 213 Participants | 445 Participants | 232 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height (inches) | 55.24 inches STANDARD_DEVIATION 15.8 | 55.09 inches STANDARD_DEVIATION 14.65 | 54.95 inches STANDARD_DEVIATION 14.53 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 59 Participants | 126 Participants | 67 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 17 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 162 Participants | 331 Participants | 169 Participants |
| Region of Enrollment United States | 226 participants | 474 participants | 248 participants |
| Sex: Female, Male Female | 124 Participants | 258 Participants | 134 Participants |
| Sex: Female, Male Male | 102 Participants | 216 Participants | 114 Participants |
| Weight (pounds) | 121.74 pounds STANDARD_DEVIATION 88.25 | 117.85 pounds STANDARD_DEVIATION 82.81 | 114.09 pounds STANDARD_DEVIATION 77.19 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 248 | 0 / 226 |
| other Total, other adverse events | 41 / 248 | 102 / 226 |
| serious Total, serious adverse events | 0 / 248 | 0 / 226 |
Outcome results
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
Time frame: 3 months after enrollment
Population: 447 of 474 participants were analyzed. The remaining 27 participants were lost to follow up for this time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Approach | Number of Participants With Incidence of SSTI at 3 Months After Decolonization | 23 Participants |
| Household Approach | Number of Participants With Incidence of SSTI at 3 Months After Decolonization | 23 Participants |
p-value: 0.757Fisher Exact
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
Time frame: 1 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Individualized Approach | Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance | 31 Isolates Analyzed/Recovered |
| Household Approach | Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance | 20 Isolates Analyzed/Recovered |
p-value: 0.84Chi-squared
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)
Time frame: 1 week
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Approach | Number of Participants Adhering to Decolonization Measures | 61 Participants |
| Household Approach | Number of Participants Adhering to Decolonization Measures | 130 Participants |
p-value: 0.143Fisher Exact
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
Time frame: 12 months after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Approach | Number of Participants Colonized With MRSA at 12 Months After Decolonization | 47 Participants |
| Household Approach | Number of Participants Colonized With MRSA at 12 Months After Decolonization | 22 Participants |
p-value: 0.005Fisher Exact
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
Time frame: 1 month after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Approach | Number of Participants Colonized With MRSA at 1 Month After Decolonization | 45 Participants |
| Household Approach | Number of Participants Colonized With MRSA at 1 Month After Decolonization | 20 Participants |
p-value: 0.004Fisher Exact
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
Time frame: 3 months after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Approach | Number of Participants Colonized With MRSA at 3 Months After Decolonization | 51 Participants |
| Household Approach | Number of Participants Colonized With MRSA at 3 Months After Decolonization | 26 Participants |
p-value: 0.006Fisher Exact
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
Time frame: 6 months after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Approach | Number of Participants Colonized With MRSA at 6 Months After Decolonization | 39 Participants |
| Household Approach | Number of Participants Colonized With MRSA at 6 Months After Decolonization | 21 Participants |
p-value: 0.05Fisher Exact
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
Time frame: 9 months after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Approach | Number of Participants Colonized With MRSA at 9 Months After Decolonization | 40 Participants |
| Household Approach | Number of Participants Colonized With MRSA at 9 Months After Decolonization | 17 Participants |
p-value: 0.007Fisher Exact
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
Time frame: 1 month after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Approach | Number of Participants Incurring Economic Burden of Performing Protocol | 75 Participants |
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.
Time frame: 1 Year
Population: 416 of 474 participants were analyzed. The remaining 58 participants were lost to follow up for this time frame and outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Approach | Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period. | 14 Participants |
| Household Approach | Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period. | 8 Participants |
p-value: 0.381Fisher Exact
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.
Time frame: 1 week after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Approach | Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period | 41 Participants |
| Household Approach | Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period | 102 Participants |
p-value: 1Fisher Exact
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
Time frame: 12 months after enrollment
Population: 417 of 474 participants were analyzed. The remaining 57 participants were lost to follow up for this time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Approach | Number of Participants With Incidence of SSTI at 12 Months After Decolonization | 48 Participants |
| Household Approach | Number of Participants With Incidence of SSTI at 12 Months After Decolonization | 41 Participants |
p-value: 0.811Fisher Exact
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
Time frame: 1 month after enrollment
Population: 449 of 474 participants were analyzed. The remaining 25 participants were lost to follow up for this time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Approach | Number of Participants With Incidence of SSTI at 1 Month After Decolonization | 8 Participants |
| Household Approach | Number of Participants With Incidence of SSTI at 1 Month After Decolonization | 8 Participants |
p-value: 1Fisher Exact
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
Time frame: 6 months after enrollment
Population: 434 of 474 participants were analyzed. The remaining 40 participants were lost to follow up for this time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Approach | Number of Participants With Incidence of SSTI at 6 Months After Decolonization | 32 Participants |
| Household Approach | Number of Participants With Incidence of SSTI at 6 Months After Decolonization | 33 Participants |
p-value: 0.687Fisher Exact
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
Time frame: 9 months after enrollment
Population: 433 of 474 participants were analyzed. The remaining 41 participants were lost to follow up for this time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Approach | Number of Participants With Incidence of SSTI at 9 Months After Decolonization | 39 Participants |
| Household Approach | Number of Participants With Incidence of SSTI at 9 Months After Decolonization | 35 Participants |
p-value: 1Fisher Exact